FDA Adverse Event
Malfunction
Summary report: N
TRIAGE PROFILER SOB 25 TEST KIT
MDR report key: 2000604
·
Received February 2, 2011
Report
- Report Number
- 2027969-2011-00238
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 5, 2011
- Report Date
- February 2, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- NBC
- 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 FIVE PATIENTS USING THE TRIAGE PROFILER SOB 25 TEST KIT. CUSTOMER IS USING THE FOLLOWING CUT OFF'S: TRIAGE: 0.05. OLD CENTAUR: <0.1 NG/ML. NEW CENTAUR: <0.1 NG/ML. NO PT INFO WAS PROVIDED. PATIENT'S 8,9,10, AND 12 USED FROZEN PLASMA SAMPLES. PT 14 SAMPLES WAS PLASMA EDTA OF THE DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE PROFILER SOB 25 TEST KIT | CARDIAC MARKER TEST | NBC | ALERE SAN DIEGO, INC. | 97300 | W47534B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |