BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCO-QUANT GLUCOSE/HK

    MDR report key: 2140551 · Received June 27, 2011

    Report

    Report Number
    1823260-2011-03459
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 31, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED AS REQUIRED INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION. THE CUSTOMER WAS UNABLE TO PROVIDE PATIENT INFORMATION BUT STATED "SHE DOES NOT BELIEVE THEY WERE ADVERSELY AFFECTED". THE RESULT WAS CORRECTED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE GLUCOSE RESULTS FOR ONE PATIENT SAMPLE WHEN TESTED ON AN ADDITIONAL D MODULE, SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS (B)(6) 2011, THE LABORATORY WAS CONTACTED BY THE PATIENT'S PHYSICIAN. HE REQUESTED THE SAMPLE BE REPEATED. THE ORIGINAL ALIQUOT AND THE PRIMARY SAMPLE TUBE WERE REPEATED ON THE SAME ANALYZER, THEY BOTH RECOVERED 97 MG/DL. THE CUSTOMER ISSUED A CORRECTED GLUCOSE RESULT OF 97 MG/DL. THE CUSTOMER DOES NOT BELIEVE THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS HAVE BEEN REPORTED. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE A CAUSE. HE VERIFIED THE ANALYZER'S PERFORMANCE WHICH WAS GOOD. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WHICH WERE WITHIN SPECIFICATION. A PRECISION CHECK WAS ALSO PERFORMED AND WAS ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1