FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PANEL 25 TEST
MDR report key: 2541328
·
Received April 12, 2012
Report
- Report Number
- 2027969-2012-00508
- Event Type
- Malfunction
- Date Received
- April 12, 2012
- Date of Event
- March 19, 2012
- Report Date
- April 12, 2012
- Manufacturer
- ALERE SAN DIEGO INC
- Product Code
- MMI
- PMA / PMN Number
- 030286
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER REPORTED A POTENTIAL FALSE POSITIVE TROPONIN (TNI) ON THE TRIAGE CARDIAC PANEL VERSUS THE LAB DEVICE. SIEMENS. WHOLE BLOOD, EDTA, FULL TUBE FROM A (B)(6) PT WAS TESTED ON BOTH TRIAGE CARDIAC PANEL AND THE LAB DEVICE. ANOTHER REPEAT RUN WAS DONE ON THE TRIAGE METER. PT WAS DISCHARGED WITH PNEUMONIA. NO INVASIVE PROCEDURES PERFORMED. NO OTHER PT INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE CARDIAC PANEL 25 TEST | CARDIAC MARKER PANEL | MMI | ALERE SAN DIEGO INC | 97000HS | W49702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |