BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1753287 · Received July 12, 2010

    Report

    Report Number
    1823260-2010-04130
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 27, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED RANDOM ERRATIC RESULTS FOR BUN, GLUCOSE, CALCIUM AND TRIGLYCERIDE ON THE ANALYTICAL D MODULE ANALYZER. OF THE DATA PROVIDED, THE GLUCOSE RESULT WAS DISCREPANT. THE SAMPLE WAS ORIGINALLY RUN ON ANOTHER MODULAR ANALYZER AND THE RESULT WAS 64 MG/DL WITH A DATA FLAG. THE USER REPEATED THE SAMPLE ON THIS ANALYZER AND RECEIVED A RESULT OF 189 MG/DL. THE USER THEN REPEATED THE SPECIMEN ON ANOTHER MODULAR ANALYZER AND RECEIVED A RESULT OF 60 MG/DL. NO RESULTS WERE VERIFIED OR REPORTED OUTSIDE THE LABORATORY. THE GLUCOSE REAGENT LOT NUMBERS WERE 62492101 AND 61610701. THE FIELD SERVICE REPRESENTATIVE SUSPECTED THE MULTI-SWITCH VALVE WAS NOT OPENING AND CLOSING WELL. HE DISASSEMBLED AND REASSEMBLED THE MULTI SWITCH VALVE. HE PERFORMED A REAGENT FLOW PATH WASH, AIR PURGE CHECK AND REAGENT RINSE AND PRIME. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED A MECHANISM CHECK AND QUALITY CONTROL. THE QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMER'S DOCUMENTED RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1