FDA Adverse Event
Malfunction
Summary report: N
TRIAGE CARDIAC PANEL KIT
MDR report key: 1864936
·
Received October 5, 2010
Report
- Report Number
- 2027969-2010-01661
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- September 15, 2010
- Report Date
- October 5, 2010
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- NBC
- PMA / PMN Number
- K030286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER REPORTED FALSE NEGATIVE TROPONIN I (TNI) RESULTS ON TRIAGE CARDIAC PANEL TEST VS. SIEMENS INSTRUMENT. CUSTOMER COMPLAINT THAT RESULTS OF TNI FROM TRIAGE TEST DID NOT COMPLY WITH THE CLINICAL PICTURE. THE PATIENT DID HAVE CLEAR SYMPTOMS OF MI, BUT THE TRIAGE CARDIAC PANEL DID NOT SHOW IT CLEARLY WHILE THE SIEMENS INSTRUMENT GAVE EXPECTED RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIAGE CARDIAC PANEL KIT | CARDIAC MARKER TEST | NBC | ALERE SAN DIEGO, INC. | 97000HS | W47697B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |