BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCO-QUANT GLUCOSE/HK

    MDR report key: 2148942 · Received July 5, 2011

    Report

    Report Number
    1823260-2011-03606
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K812303/K953
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE GLUCOSE RESULTS FOR SIX PATIENT SAMPLES FROM THE ANALYTICAL D MODULE SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR FOUR PATIENT SAMPLES WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. ALL REPEAT TESTING WAS PERFORMED ON A DIFFERENT D MODULE ANALYZER. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 167 AND THE REPEAT RESULT WAS 96. PATIENT SAMPLE 2 INITIAL RESULT WAS 169 AND THE REPEAT RESULT WAS 88. PATIENT SAMPLE 3 INITIAL RESULT WAS 196 AND THE REPEAT RESULT WAS 110. PATIENT SAMPLE 4 INITIAL RESULT WAS 197 AND THE REPEAT RESULT WAS 96. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE GLUCOSE R2 REAGENT LOT NUMBER WAS 63937801. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PIN HOLE IN THE R2 REAGENT LINE. HE REPLACED A CHANGE VALVE, REPLACED THE R1 AND R2 REAGENT LINES AND THE MULTIPORT VALVE. TO VERIFY THE ANALYZER OPERATION, HE RAN CALIBRATION AND QUALITY CONTROL WITH ALL RESULTS WITHIN THE USER'S RANGES. HE ALSO RAN PRECISION TESTING WITH RESULTS WITHIN THE SPECIFIED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCO-QUANT GLUCOSE/HK HEXOKINASE, GLUCOSE CFR ROCHE DIAGNOSTICS NA 63619201

    Patients

    Seq Age Sex Outcome Treatment
    1