BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXOKINASE, GLUCOSE

    MDR report key: 2112757 · Received June 3, 2011

    Report

    Report Number
    1823260-2011-02989
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE GLUCOSE RESULTS FROM THE ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4) THAT WERE DISCOVERED WHEN A PHYSICIAN CALLED QUESTIONING THE RESULTS. THE USER STATED THE GLUCOSE RESULTS FOR 49 PATIENT SAMPLES HAD TO BE CORRECTED; HOWEVER DATA WAS ONLY PROVIDED FOR FOUR PATIENT SAMPLES. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 251 AND THE REPEAT RESULT WAS 98. PATIENT SAMPLE 2 INITIAL RESULT WAS 234 AND THE REPEAT RESULT WAS 80. PATIENT SAMPLE 3 INITIAL RESULT WAS 166 AND THE REPEAT RESULT WAS 98. PATIENT SAMPLE 4 INITIAL RESULT WAS 241 AND THE REPEAT RESULT WAS 90. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER DID NOT THINK ANY PATIENTS WERE ADVERSELY AFFECTED. THE GLUCOSE R1 REAGENT LOT NUMBER WAS 63619201. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDIC FAILURE AND A VALVE AND THE ASSOCIATED TUBING WERE CLOGGED. HE REPLACED THE VALVE, CLEANED THE ASSOCIATED TUBING, REPLACED THE REACTION CELLS AND PERFORMED A CELL BLANK. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED PRECISION TESTING AND VERIFIED THE RESULTS WERE WITHIN THE GUIDELINES. THE USER RAN CALIBRATION, QUALITY CONTROL WITH RESULTS WITHIN THE RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEXOKINASE, GLUCOSE GLUCO-QUANT GLUCOSE/HK CFR ROCHE DIAGNOSTICS NA 63937801

    Patients

    Seq Age Sex Outcome Treatment
    1