FDA Adverse Event
Malfunction
Summary report: N
COBAS INTEGRA 800
MDR report key: 1191582
·
Received October 1, 2008
Report
- Report Number
- 1823260-2008-07299
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- September 3, 2008
- Report Date
- October 1, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K951595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER EXPERIENCING LOW CK RESULTS FOR ONE PATIENT. PHYSICIAN QUESTIONED THE LOW CK RESULTS. THE RESULTS DID NOT FIT CLINICAL PICTURE. INITIAL RESULT GAVE <5 U/L; REPEAT ON DIFFERENT ANALYZER GAVE 15 U/L. A SECOND SAMPLE WAS OBTAINED THE NEXT DAY AND REPEATED TWICE GIVING 1 U/L EACH TIME. SAMPLE WAS REPEATED AN ADDITIONAL THREE TIMES, TWICE WITH DILUTION GIVING 2 U/L EACH TIME, AND ONCE WITHOUT DILUTION ON DIFFERENT ANALYZER GIVING 15 U/L. THE PATIENT WAS NOT TREATED BASED ON THE LOW CK RESULTS. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS INTEGRA 800 | CLINICAL CHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | I800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | PROZAC| PREDNISONE - 20 MG TID| TOPROL| CELLCEPT - 20 MG BID| PLAQUENIL| BENICAR| LASIX| PROTONIX |