BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1585349 · Received January 19, 2010

    Report

    Report Number
    1823260-2010-00331
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJY
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS INTERMITTENT IMPROPER AV1 AND AV2 VALVE OPERATION. HE REPLACED THE VALVES CONTROLLING EXTERNAL PROBE WASH/RINSE BATH VOLUMES, VALVES CONTROLLING RINSE MECHANISM FLUID VOLUMES AND LEVELS, AND VALVES CONTROLLING INTERNAL WASH VOLUMES FOR REAGENT AND SAMPLE PROBES. HE ALSO FLUSHED THE SAMPLE PROBE. TO VERIFY THE ANALYZER OPERATION, HE RAN AND OBSERVED MECHANISM CHECKS FOR OPERATION AND ADJUSTMENTS, VERIFIED ALL FLUID LEVELS AND GAUGE PRESSURES FOR RINSE BATHS AND HEAD MECHANISM, MANUALLY VERIFIED THE INTERNAL RINSE VOLUMES FOR THE REAGENT AND SAMPLE PROBES. HE RAN QUALITY CONTROL WITH CALCIUM RESULTS ON OR NEAR THE MEAN.

    Description of Event or Problem · 1

    THE USER NOTICED ISSUES WITH CALCIUM RESULTS AND STATED THE ISSUE WAS WITH REAGENT LOTS 61689501, 61480901 AND 616917. THE OTHER COBAS 6000 AT THE SITE USING REAGENT LOT 61867901 HAS NOT ISSUES. THE USER PROVIDED DATA FOR QC MATERIAL RUN ON BOTH ANALYZERS OF WHICH SEVEN SETS OF RESULTS WERE DISCREPANT. ALL RESULT ARE IN MG PER DL AND ARE THE RESULT FROM COBAS 1 (B)(4) FOLLOWED BY THE RESULT FROM COBAS 2 (B)(4). LEVEL 1 QC AT 11:00 WAS 9.0, 7.2; RUN AT 15:30 WAS 9.1, 7.9; RUN AT 17:30 WAS 9.5, 8.7 AND RUN AT 21:30 WAS 9.5, 8.6. LEVEL 2 QC RUN AT 11:00 WAS 13.4, 12.3; RUN AT 19:30 WAS 14.2, 13.0 AND RUN AT 21:30 WAS 14.1. 13.2. PATIENT DATA WAS ALSO PROVIDED, THE RESULTS FOR TWO PATIENT SERUM SAMPLES WERE DISCREPANT. SAMPLE 1 FROM AN (B)(6) FEMALE, INITIAL RESULT WAS 6.9 WITH A DATA FLAG NOTIFYING THE USER THE RESULT WAS OUTSIDE OF THEIR EXPECTED RANGE. THE REPEAT RESULT ON COBAS 1 WAS 8.2 WITH A DATA FLAG NOTIFYING THE USER THE RESULT WAS OUTSIDE OF THEIR EXPECTED RANGE. THE USER DID NOT REPORT ANY RESULTS FOR THE PATIENT SAMPLES AND NO PATIENTS WERE TREATED BASED ON THE RESULTS.

    Additional Manufacturer Narrative · 2

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS INTERMITTENT IMPROPER AV1 AND AV2 VALVE OPERATION. HE REPLACED THE VALVES CONTROLLING EXTERNAL PROBE WASH/RINSE BATH VOLUMES, VALVES CONTROLLING RINSE MECHANISM FLUID VOLUMES AND LEVELS, AND VALVES CONTROLLING INTERNAL WASH VOLUMES FOR REAGENT AND SAMPLE PROBES. HE ALSO FLUSHED THE SAMPLE PROBE. TO VERIFY THE ANALYZER OPERATION, HE RAN AND OBSERVED MECHANISM CHECKS FOR OPERATION AND ADJUSTMENTS, VERIFIED ALL FLUID LEVELS AND GAUGE PRESSURES FOR RINSE BATHS AND HEAD MECHANISM, MANUALLY VERIFIED THE INTERNAL RINSE VOLUMES FOR THE REAGENT AND SAMPLE PROBES. HE RAN QUALITY CONTROL WITH CALCIUM RESULTS ON OR NEAR THE MEAN.

    Description of Event or Problem · 2

    THE USER NOTICED ISSUES WITH CALCIUM RESULTS AND STATED THE ISSUE WAS WITH REAGENT LOTS 61689501, 61480901 AND 616917. THE OTHER COBAS 6000 AT THE SITE USING REAGENT LOT 61867901 HAS NOT ISSUES. THE USER PROVIDED DATA FOR QC MATERIAL RUN ON BOTH ANALYZERS OF WHICH SEVEN SETS OF RESULTS WERE DISCREPANT. ALL RESULT ARE IN MG PER DL AND ARE THE RESULT FROM COBAS 1 (B)(4) FOLLOWED BY THE RESULT FROM COBAS 2 (B)(4). LEVEL 1 QC AT 11:00 WAS 9.0, 7.2; RUN AT 15:30 WAS 9.1, 7.9; RUN AT 17:30 WAS 9.5, 8.7 AND RUN AT 21:30 WAS 9.5, 8.6. LEVEL 2 QC RUN AT 11:00 WAS 13.4, 12.3; RUN AT 19:30 WAS 14.2, 13.0 AND RUN AT 21:30 WAS 14.1. 13.2. PATIENT DATA WAS ALSO PROVIDED, THE RESULTS FOR TWO PATIENT SERUM SAMPLES WERE DISCREPANT. SAMPLE 2, INITIAL RESULT WAS 8.6, REPEAT RESULT ON COBAS 1 WAS 10.0. THE USER DID NOT REPORT ANY RESULTS FOR THE PATIENT SAMPLES AND NO PATIENTS WERE TREATED BASED ON THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM CJY ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR
    2 47 YR