BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUC3 GLUCOSE HK GEN.3

    MDR report key: 8443309 · Received March 22, 2019

    Report

    Report Number
    1823260-2019-01177
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    March 5, 2019
    Report Date
    April 29, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K061048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RELEVANT TESTS LABORATORY DATA AND OTHER RELEVANT HISTORY WERE UPDATED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR GLUC3 GLUCOSE HK (GLUC3) ON A COBAS 6000 C (501) MODULE. THE CUSTOMER WAS COMPARING RESULTS BETWEEN THE NAF SAMPLE TUBE AND THE RESULTS FROM THE LITHIUM-HEPARIN SAMPLE TUBE. THE INITIAL RESULT FROM THE NAF TUBE 1162 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED AND THE RESULT WAS 1715 MG/DL. THE INITIAL RESULT FROM THE LITHIUM-HEPARIN TUBE WAS 173 MG/DL. THE RESULT OF 1715 MG/DL WAS REPORTED OUTSIDE OF THE LABORATORY. THE NAF TUBE WAS REPEATED WITH A RESULT OF 1061 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A RESULT OF 1645 MG/DL. ON (B)(6) 2019 THE LITHIUM-HEPARIN TUBE WAS REPEATED WITH A RESULT OF 141 MG/DL. THE NAF TUBE WAS REPEATED AGAIN WITH A RESULT OF 1134 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A RESULT OF 1663 MG/DL. ON (B)(6) 2019 THE LITHIUM-HEPARIN TUBE WAS REPEATED AGAIN WITH A RESULT OF 100 MG/DL. THE NAF TUBE WAS REPEATED AGAIN WITH A RESULT OF 1074 MG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A RESULT OF 1618 MG/DL WITH A DATA FLAG. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE C501 MODULE SERIAL NUMBER WAS (B)(4). THE CUSTOMER WAS NOT HAVING ISSUES WITH OTHER ASSAYS, CALIBRATION AND QC WERE ACCEPTABLE AND INSTRUMENT MAINTENANCE WAS UP TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238852 GLUC3 GLUCOSE HK GEN.3 HEXOKINASE, GLUCOSE CFR ROCHE DIAGNOSTICS NA 371182

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO