FDA Adverse Event
Malfunction
Summary report: N
COBAS 6000 C501 MODULE
MDR report key: 1970174
·
Received January 25, 2011
Report
- Report Number
- 1823260-2011-00378
- Event Type
- Malfunction
- Date Received
- January 25, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 25, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CJI
- PMA / PMN Number
- K060373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CUSTOMER HAS RECEIVED INSTRUMENT ERRORS AND QUESTIONABLE ALKALINE PHOSPHATASE GEN.2 (ALP2) RESULTS SINCE (B)(6) 2010. SHE PROVIDED ALP2 RESULTS FOR TEN PATIENT SAMPLES, ONE SAMPLE HAD DISCREPANT RESULTS. THE ORIGINAL RESULT WAS 11 U/L. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 6000 C501 (SERIAL NUMBER (B)(4)) AND RECOVERED 124 U/L. THE ORIGINAL RESULT WAS REPORTED OUTSIDE THE LABORATORY AND A CORRECTED REPORT WAS SENT OUT THE SAME DAY. NO PATIENTS WERE ADVERSELY AFFECTED BY THE EVENT. THE ALP2 REAGENT LOT NUMBER WAS 63013201. THE FIELD SERVICE REPRESENTATIVE CONTACTED THE CUSTOMER. THE CUSTOMER PERFORMED MAINTENANCE WHICH RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBAS 6000 C501 MODULE | CLINICAL CHEMISTRY ANALYZER | CJI | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |