Alere Triage Meter Pro User Manual
A troponin was requested by the ed physician, and the lab ran the troponin on their immunochemistry analyzer instead of the triage meter in the ed. The result of the lab assay was 0. 85ng/ml which was reported to the ed. This result is considered positive for possible mi. The ed nurse also ran the troponin on the alere triage point of care analyzer in the ed. This cardioprofiler assay yielded a 0. 16ng/ml result, which is considered negative. The tech called the positive troponin to the ed and the nurse recognized the discrepancy since she had just run the test on the triage and got a negative result. The point of care lab supervisor was notified of this incident on (b)(6) 2012, and investigated the variance. The pt was still in the hosp, so the tech collected a new set of troponins which were run in parallel on the chemistry analyzer and on the triage meter. The lab troponin result was clearly positive at 2. 77ng/ml and the triage meter result was 0. 57ng/ml. The (b)(6) tech called the ed physician and reported her findings. The ed physician was very concerned stating that 'had this pt's blood only be run on the point of care cardiac profiler meter that the pt could have been discharged with two negative troponins when actually they were positive by the lab analyzer. ' the lab (b)(6) and the ed physician discussed the issue at length and the (b)(6) called alere immediately to report the issue. Alere responded immediately with info stating that we should be using the panel of results instead of the one troponin result for diagnosis. Alere's response was unacceptable to the ed physician so the triage meter was taken out of service pending further investigation. Another ed physician requested immediate conference call with the (b)(6) and alere. The (b)(6) tech requested that the alere (b)(6) speak on this call. The call took place on (b)(6) 2012. The hosp personnel on the call were dr (b)(6) (ed doctor), dr (b)(6), (b)(6) (b)(6), and (b)(6). Alere announced that they would be recording the call. The lab (b)(6) presented the info about the test results and immediately (b)(6), alere, stated that 'i know exactly what happened here. ' he went on to state 'the range for positive troponins for our test should be set at 0. 15ng/ml. Upon implementation of the assay, the alere rep had set the positive cutoff value at 0. 41ng/ml. Neither (b)(6) nor (b)(6) was ever notified of this info, so we asked why this info was not communicated to us and how long this change had been in effect. (b)(6) stated that our chemistry analyzer runs at a 30% greater result level than our point of care cardiac profiler meter. We asked why the package insert stated. 41ng/ml or greater was positive if this info was known by alere. The info we are referencing that should have been indicated by the package insert is 'a positive should actually be 0. 15 ng/ml or greater'. (b)(6) stated 'well you have to understand the business aspect of this. ' 'to get a package insert changed and approved by the fda is very hard. It's very time consuming and very costly'. Dr (b)(6) answered back asking if the package insert could be changed to reflect accurate info, and if not, why had the consumer not been advised. -us-. Alere did not respond to the question. We ended the call with the decision to validate internally the positive range of the meter. We did not feel that alere's recommendation of changing the positive range to be acceptable. Validation is still ongoing. Borderline positive results and not correlating with the chemistry analyzer. The alere sales rep (b)(6), made an unannounced visit to (b)(6) on (b)(4) 2012 to express his apologies about the nature of the call and stated that he felt some of the alere statements were unacceptable. He stated he would be sending a certified letter of apology and an explanation within 10 days. Alere letter as follows: '(b)(6) 2012; dear hospital staff members: it has come to my attention that something i may have said on our (b)(6) conference call caused you a great deal of consternation. Whereas i don't remember saying anything that should upset you, it was 7 am where i was calling from so anything is possible. Regardless, it is never my intent to say anything that would suggest a customer is ignorant of something, whether it is something they would be expected to know or not. My intension was simply to describe the situation alere, or any other diagnostic company, faces with the fda when it comes to trying to make changes to a product package insert. This is something i would not expect you to know about since it isn't something you would ever deal with and i am extremely sorry if i phrased it in a way that you would take offense to. That certainly was not my intent. I have a great deal of respect for healthcare professionals such as yourselves. I understand the challenges you face on a daily basis and i laud you for the work you do. Please accept my sincerest apology. Respectfully, (b)(6)'.
Triage Meter Pro Manual
Shop Testing Kits & Supplies. Allergy Testing. Clinical Chemistry Analyzers. Clostridium Difficile Testing. Drug Testing. Fecal Occult Blood Testing. Lead Testing. Mono Testing. Pregnancy Kits. Respiratory Syncytial Virus Testing. Strep Testing. Triage Testing. Urine Albumin Testing. Alere Triage MeterPro D-Dimer Method and Sample Collection IECDD.5.v1 29.3.12 1 Alere™ Triage® MeterPro D-Dimer METHOD AND SAMPLE COLLECTION 1. PURPOSE AND SCOPE The purpose of this document is to describe the procedure for performing a D-Dimer.
Alere Triage Meter Pro Service Manual
Biosite, Inc. Abbott™ Biosite™ Triage™ Drugs of Abuse Panel Immunoassay for the qualitative determination of the presence of parent compound and/or major metabolites of up to. View and Download Alere Triage MeterPro user manual online. Canon imagerunner advance c2020 user manual. Triage MeterPro Measuring Instruments pdf manual download. Gently insert the test device into the Alere Triage Meter until you feel the ® device catch on the pin. You will hear an audible ‘click’ that tells you the. Jul 18, 2011 Get YouTube without the ads. Skip trial 1 month free. Find out why Close. Triage MeterPro I SanmedicoMoldova. Unsubscribe from SanmedicoMoldova? Alere Triage ® MeterPro 55070, Refurbished The Alere Triage ® MeterPro 55070 is a comprehensive testing platform for use in the laboratory or at the point of care. The comprehensive test menu includes cardiovascular, renal, toxicology, and women’s health assays (some assays not available in the USA).
The CR-V is widely acclaimed for its stylish looks and great performance. As stated by Honda) which is the smallest SUV offered by Honda Motor Corporation. 