BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1904649 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06848
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR FIVE PATIENTS INVOLVING MULTIPLE ASSAYS. SHE PROVIDED DISCREPANT CREATININE JAFFE GENERATION 2 (CREATININE) AND GLUCOSE HK GENERATION 3 (GLUCOSE) RESULTS FOR THREE PATIENT SAMPLES. THE CUSTOMER REPEATED THE SAMPLES BECAUSE SHE KNEW THE PATIENTS DID NOT HAVE RENAL FAILURE OR DIABETES. THE SAMPLES WERE REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER. PATIENT 1, INITIAL CREATININE RESULT WAS 7.6 MG/DL. THE CREATININE REPEAT RESULT WAS 0.8 MG/DL. PATIENT 2, INITIAL CREATININE RESULT WAS 7.2 MG/DL. THE CREATININE REPEAT RESULT WAS 1.1 MG/DL. THE INITIAL GLUCOSE RESULT WAS 134 MG/DL. THE GLUCOSE REPEAT RESULT WAS 95 MG/DL. PATIENT 3, INITIAL CREATINE RESULT WAS 0.5 MG/DL. THE CREATININE REPEAT RESULT WAS 1.1 MG/DL. THE INITIAL GLUCOSE RESULT WAS 414 MG/DL. THE GLUCOSE REPEAT RESULT WAS 93 MG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. CORRECTIONS WERE MADE FOLLOWING GENERATION OF THE REPEAT RESULTS. THE PATIENTS WERE NOT AFFECTED BY THE DISCREPANCIES. THE CREATININE REAGENT USED FOR TESTING WAS (B)(4). THE GLUCOSE REAGENT USED FOR TESTING WAS (B)(4). THE FIELD SERVICE REPRESENTATIVE DETERMINED MALFUNCTIONING VALVES WERE THE CAUSE OF THE ISSUE. HE REPLACED THE VALVES AND VACUUM PUMP DIAPHRAGMS. AFTER THE FIELD SERVICE REPRESENTATIVE REPLACED ALL PARTS NEEDED TO RESOLVE THE FLUIDIC FAILURE, THE CUSTOMER RAN CALIBRATIONS AND QUALITY CONTROL WHICH WERE ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1