FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PANEL 25 TEST
MDR report key: 2515368
·
Received March 29, 2012
Report
- Report Number
- 2027969-2012-00425
- Event Type
- Malfunction
- Date Received
- March 29, 2012
- Date of Event
- February 23, 2012
- Report Date
- March 29, 2012
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- MMI
- PMA / PMN Number
- K030286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED FALSE POSITIVE TROPONIN (TNI) RESULTS. RESULTS AS FOLLOWS: THE CUSTOMER CALLED BECAUSE THEY WERE FAILING CONTROLS ON TWO DIFFERENT LOT NUMBERS OF DEVICES. PATIENT WAS ADMITTED WITH SHORTNESS OF BREATH, CHEST PAIN, AND LIGHT HEADED. REFERENCE RANGE: (B)(4) NORMAL, ABNORMAL >0.4 SAMPLE: WHOLE BLOOD. ADDITIONAL TESTS CPK AND EKG WERE DONE: RESULTS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE CARDIAC PANEL 25 TEST | CARDIAC MARKER TEST | MMI | ALERE SAN DIEGO, INC. | 97000HS | W49729B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |