MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-12-29 for TRIAGE CARDIO PROFILER PANEL 97100CP manufactured by Alere San Diego, Inc..
[63625367]
Investigation conclusion: the device lot was recalled for potential performance issues back in 2012. Corrections: maude report incorrectly lists: (b)(6). Correction: (b)(6), us correction: device is not available for evaluation. The maude event type is incorrectly listed as an injury. No injury reported this is not an adverse event.
Patient Sequence No: 1, Text Type: N, H10
[63625368]
The complaint is based on a maude report of 03/16/2012. Report#: mw5025345. Copy of report is listed below. A customer emailed an alere representative about a request to set up triage tni cutoff and referenced this report on 12/29/2015. Report details: a troponin was requested by the emergency department physician, and the lab ran the troponin on their immunochemistry analyzer instead of the triage meter in the emergency department. The result of the lab assay was 0. 85 ng/ml which was reported to the emergency department. This result is considered positive for possible mi. The emergency department nurse also ran the troponin on the alere triage point of care analyzer in the emergency department. This cardioprofiler assay yielded a 0. 16 ng/ml result, which is considered negative. The tech called the positive troponin to the emergency department and the nurse recognized the discrepancy since she had just run the test on the triage and received a negative result. The point of care lab supervisor was notified of this incident on (date unknown), 2012, and investigated the variance. The patient was still in the hospital 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. 77 ng/ml and the triage meter result was 0. 57 ng/ml. The tech called the emergency department physician and reported her findings. The emergency department physician was very concerned stating that "had this patient's blood only been run on the point of care cardiac profiler meter that the patient could have been discharged with two negative troponins when actually they were positive by the lab analyzer. " the following is the description that was listed on the maude report of 03/16/2012. Alere inc alere triage meter pro & plus triage cardioprofiler troponin assay. Lot number w49626, event date (b)(6) 2012, event type injury, event description: 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. 85 ng/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. 16 ng/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. 77 ng/ml and the triage meter result was 0. 57 ng/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). 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. 15 ng/ml. Upon implementation of the assay, the alere rep had set the positive cutoff value at 0. 41 ng/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. 41 ng/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,
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027969-2016-00711 |
| MDR Report Key | 6214530 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-12-29 |
| Date of Report | 2015-12-29 |
| Date of Event | 2012-03-06 |
| Date Mfgr Received | 2015-12-29 |
| Date Added to Maude | 2016-12-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YA-LING KING |
| Manufacturer Street | 9975 SUMMERS RIDGE ROAD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052084 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGE CARDIO PROFILER PANEL |
| Generic Name | TRIAGE CARDIO PROFILER PANEL |
| Product Code | NBC |
| Date Received | 2016-12-29 |
| Model Number | 97100CP |
| Lot Number | W49626B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | 9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-29 |