FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PANEL KIT (25T)
MDR report key: 3182578
·
Received June 14, 2013
Report
- Report Number
- 2027969-2013-00476
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 8, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- MMI
- PMA / PMN Number
- K030286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW TROPONIN (TNI RESULTS: RESULTS AS FOLLOWS: PT HAS BEEN IN THE HOSPITAL FROM (B)(6) TO (B)(6). THE DIAGNOSTIC RESULT IS: CHF, HYPERTENSIVE HEART DISEASE, DM TYPE II, CKB STAGE IV, HYPOALBUMINEMIN, ANEMIA, GERE AND EU. THE FOLLOWING CUT OFF'S WERE USED: TRIAGE: CKMB: 0.0-4.3 NORMAL, >4.3 ABNORMAL. MYO: 0.0-107 NORMAL, >107 ABNORMAL. TNI: 0.00-0.40 NORMAL, >0.40 ABNORMAL. ACCESS 2: AMI CUT OFF: <0.5 NG/ML. UPPER REFERENCE LIMIT: 0.04 NG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272099 | TRIAGE CARDIAC PANEL KIT (25T) | CARDIAC MARKER TEST | MMI | ALERE SAN DIEGO, INC. | BS97000HS | 52798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |