FDA Adverse Event
Malfunction
Summary report: N
COBAS 6000 C501 MODULE
MDR report key: 3052462
·
Received April 11, 2013
Report
- Report Number
- 1823260-2013-02212
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 21, 2013
- Report Date
- April 26, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K060373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURED IN (B)(6).
Additional Manufacturer Narrative · 1
A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE REACTION KINETICS PROVIDED FOR INVESTIGATION FOR BOTH SAMPLES APPEARED NORMAL.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE CHOLESTEROL GEN.2 (CHOL) RESULT FOR ONE PATIENT ON THEIR C501 ANALYZER. THE PATIENT'S INITIAL CHOL RESULT WAS 9.06 MMOL/L. THE CUSTOMER STATED THE PATIENT WAS SHOCKED TO FIND HER CHOL LEVEL HIGHER THAN PREVIOUS ONES. THE REPEAT RESULT WAS 4.79 MMOL/L. THERE WERE NO ADVERSE EVENTS. THE CHOL REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156759 | COBAS 6000 C501 MODULE | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 046 YR |