FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PANEL 25 TEST
MDR report key: 1518039
·
Received October 19, 2009
Report
- Report Number
- 2027969-2009-00943
- Event Type
- Malfunction
- Date Received
- October 19, 2009
- Date of Event
- September 29, 2009
- Report Date
- October 19, 2009
- Manufacturer
- BIOSITE INCORPORATED
- Product Code
- MMI
- PMA / PMN Number
- 030286
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER REPORTED POTENTIAL FALSE POSITIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL TEST VS. RESULTS ON VISTA. A MALE PRESENTED WITH MOUTH NUMBNESS; TOX SCREEN AND ETOH NEGATIVE. NOT ADMITTED. AT 4:41, GREEN-TOP TUBE RUN ON VISTA ANALYZER. RE-RUN 3 DAYS LATER, AND GOT SAME RESULTS. AT 5:27, A LAVENDER TOP TUBE (LTT) RUN ON METER. AT 5:58 RECOLLECT REQUESTED PER PHYSICIAN, LTT RUN ON METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE CARDIAC PANEL 25 TEST | CARDIAC MARKER TEST | MMI | BIOSITE INCORPORATED | 97000HS | W46065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |