BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1908674 · Received November 29, 2010

    Report

    Report Number
    1823260-2010-07004
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NQD
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. FURTHER INFORMATION WAS NOT AVAILABLE FOR INVESTIGATION. INFORMATION PROVIDED INDICATES THE SAMPLE WITH THE LOW VALUE WAS NOT PROCESSED ACCORDING TO THE CUSTOMER'S NORMAL ROUTINE PROCEDURE, WHICH IS USUALLY PERFORMED ON THE MPA AS THE CUSTOMER HAD PROBLEMS WITH OIL IN THE TOP SERUM/PLASMA LAYER AND GEL AT THE TUBE WALLS LAST YEAR WITH MANUALLY PROCESSED SAMPLES, THE LOW RESULTS MAY HAVE BEEN CAUSED BY PREANALYTICAL INTERFERENCE AND NOT BY ANY INSTRUMENT INSUFFICIENCY. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MICRO OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE WIRE IN THE SNARE LOOP BROKE DURING THE PROCEDURE. NO PART OF THE SNARE DETACHED OR FELL INTO THE PATIENT, AND NO PROBLEMS WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION MICRO OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE C-REACTIVE PROTEIN GENERATION 3 (CRP) RESULT FOR ONE PATIENT SAMPLE. ALL RESULTS ARE IN MG/L. THE INITIAL RESULT WAS 0.04 AND WAS REPORTED OUTSIDE THE LABORATORY AS < 0.1 MG/L. THE DOCTOR DID NOT BELIEVE THE RESULT BECAUSE THEY HAD RUN A CRP ASSAY ON A NEAR PATIENT TESTING INSTRUMENT AND RECEIVED A RESULT OF 78. THE SAMPLE WAS REPEATED ON ANOTHER COBAS INSTRUMENT AND THE RESULT WAS 79.87. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CRP REAGENT LOT NUMBER WAS 63067501.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER NQD ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR