FDA Adverse Event
Malfunction
Summary report: N
ELECSYS 2010 DISK
MDR report key: 1003484
·
Received February 21, 2008
Report
- Report Number
- 1823260-2008-01749
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 28, 2008
- Report Date
- February 21, 2008
- Manufacturer
- ROCHE DIAGNOSTICS CORP.
- Product Code
- MMI
- PMA / PMN Number
- K961481
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ONE PT SAMPLE WITH DISCREPANT TROPONIN T RESULTS. INITIAL RESULT GAVE 1.38 NG/ML. SAME SAMPLE REQUESTED GAVE RESULT <0.010 NG/ML. SAMPLE REPEATED A THIRD TIME GAVE RESULT OF 1.41 NG/ML. A PLASMA TUBE FROM THE SAME PT DRAWN THE SAME DAY GAVE A RESULT OF 0.016 NG/ML. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS A PROBLEM WITH THE SAMPLE STATIC BRUSH AND REPLACED THE BRUSH. PERFORMANCE TEST WERE PERFORMED AND WITHIN SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECSYS 2010 DISK | IMMUNOCHEMISTRY ANALYZER -JJE | MMI | ROCHE DIAGNOSTICS CORP. | 2010 DISK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | DIAZEPAM| ASPIRIN| TRIAMTE| NITROGLYCERIN| MORPHINE |