FDA Adverse Event
Malfunction
Summary report: N
CARDIAC READER
MDR report key: 1232715
·
Received November 14, 2008
Report
- Report Number
- 1823260-2008-08433
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- October 14, 2008
- Report Date
- November 14, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- MMI
- PMA / PMN Number
- K000784
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER EXPERIENCED TWO SAMPLES FROM ONE PATIENT, BOTH GIVING HIGH TROPONIN T RESULTS. SAMPLE 1 INITIAL RESULT 1.8 NG/ML, REPEATED 2008 GAVE <0.010 UG/L. SAMPLE 2 INITIAL RESULT>2.0 NG/ML, REPEATED 2008 GAVE <0.010 UG/L. ADDITIONALLY, ONE OF THE SAMPLES WAS REPEATED TWICE GIVING 1.9 AND 1.6 NG/ML. NO INFORMATION PROVIDED TO DETERMINE DATE OF REPEAT ANALYSIS OR WHICH SAMPLE WAS REPEATED. INITIAL RESULTS WERE REPORTED. THE CUSTOMER IS CONCERNED THAT THE PATIENT MAY HAVE HAD UNNECESSARY INTERVENTION. NO INFORMATION HAS BEEN PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY OR IF UNNECESSARY INTERVENTION DID OCCUR. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIAC READER | CARDIAC READER SYSTEM-MMI | MMI | ROCHE DIAGNOSTICS | CARDIAC READER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |