FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PROFILER
MDR report key: 2050378
·
Received April 4, 2011
Report
- Report Number
- 2027969-2011-00702
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 10, 2011
- Report Date
- April 4, 2011
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- NBC
- PMA / PMN Number
- 030286
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER REPORTED FALSE POSITIVE TROPONIN (TNI) RESULTS ON THE TRIAGE CARDIAC PROFILER COMPARED TO ANOTHER DEVICE, ACCESS II FROM A (B)(6) FEMALE WHO WENT TO THE EMERGENCY DEPARTMENT. PHYSICIANS AT THE EMERGENCY DEPARTMENT STATED NO CLINICAL CORRELATION BETWEEN TRIAGE RESULTS AND LAB PT CONDITION. PT WAS STILL IN THE EMERGENCY DEPARTMENT AND IT WAS NOT KNOWN IF THE PT WAS ADMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE CARDIAC PROFILER | CARDIAC MARKER PANEL | NBC | ALERE SAN DIEGO, INC | 97100CP | W48357B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |