FDA Adverse Event
Malfunction
Summary report: N
COBAS 6000 E601 MODULE
MDR report key: 1030595
·
Received April 16, 2008
Report
- Report Number
- 1823260-2008-03279
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Date of Event
- March 20, 2008
- Report Date
- April 16, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CEM
- PMA / PMN Number
- K060373
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER EXPERIENCING DISCREPANT TSH RESULTS SINCE 2008. ONLY THE FOLLOWING THREE EXAMPLES WERE PROVIDED, WHICH OCCURRED ON OR AFTER 2008. PATIENT 1, 2008, INITIAL RESULT 0.133 UIU/ML, REPEAT GAVE 7.78 UIU/ML. PATIENT 2, 2008, INITIAL RESULT 0.091 UIU/ML, REPEAT GAVE 1.47 UIU/ML. PATIENT 3, 2008, INITIAL RESULT 0.077 UIU/ML, REPEAT GAVE 2024 UIU/ML. INITIAL RESULTS WERE NOT REPORTED. CUSTOMER REFUSED VISIT FROM FIELD SERVICE REPRESENTATIVE. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS 6000 E601 MODULE | IMMUNOCHEMISTRY ANALYZER - CEM | CEM | ROCHE DIAGNOSTICS | C601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |