FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PANEL 25 TEST
MDR report key: 2121288
·
Received May 5, 2011
Report
- Report Number
- 2027969-2011-00995
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 13, 2011
- Report Date
- May 5, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- MMI
- PMA / PMN Number
- K030286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 USING THE TRIAGE CARDIAC PANEL. EMERGENCY DEPT PT; INITIAL SYMPTOMS: UNK. NO SPECIFIC CLINICAL INFO WAS GIVEN. FULL DRAW, WB-EDTA. REFERENCE RANGES: CK-MB 0.0 TO 8.0. TNI 0.0 TO 0.05. MYO 0.0 TO 149.
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 | W48769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |