FDA Adverse Event
Malfunction
Summary report: N
TRIAGE PROFILER SOB 25 TEST KIT
MDR report key: 2000603
·
Received February 2, 2011
Report
- Report Number
- 2027969-2011-00235
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- December 15, 2010
- Report Date
- February 2, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- MMI
- PMA / PMN Number
- K042723
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER REPORTED FALSE NEGATIVE TROPONIN (TNI) RESULTS ON ONE PT USING THE TRIAGE PROFILER SOB 25 TEST KIT. PT ARRIVED AT THE EMERGENCY AND HAD ACS. TRIAGE TESTING WAS DONE AT 9:00 AM WITH SAMPLE TESTS RUN IMMEDIATELY AFTER. CUSTOMER IS USING THE FOLLOWING CUT OFF'S: TRIAGE: 0.05. CENTAUR: <0.1 NG/ML. ARCHITECT: <0.3 NG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE PROFILER SOB 25 TEST KIT | CARDIAC MARKER TEST | MMI | ALERE SAN DIEGO, INC. | 97300 | W47520B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |