FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PANEL TEST
MDR report key: 1070761
·
Received July 3, 2008
Report
- Report Number
- 2027969-2008-00007
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- May 29, 2008
- Report Date
- July 3, 2008
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- MMI
- PMA / PMN Number
- K030286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT INVESTIGATION PENDING.
Description of Event or Problem · 1
PATIENT INITIALLY TESTED WITH TRIAGE CARDIO PROFILER WHICH GAVE RESULTS OF TROPONIN I (TNI) ,<0.05 NG/ML. BLOOD DRAW TAKEN 90 MINUTES LATER TESTED WITH TRIAGE CARDIAC PANEL AND SHOWED ELEVATED TNI = 0.14 NG/ML. PATIENT WAS ADMITTED TO HOSPITAL. TESTING WS REPEATED 8 HOURS LATER WITH ACCESS TNI AND RESULTS SHOWED NORMAL LEVELS OF TNI = 0.01 NG/ML. PATIENT HAD COUGHS, BODY ACHES, LIGHT HEADACHE, NO CHEST PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE CARDIAC PANEL TEST | CARDIAC PANEL TEST | MMI | BIOSITE INCORPORATED | 97000HS | W42372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |