BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA-GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZAS

    MDR report key: 24833575 · Received April 9, 2026

    Report

    Report Number
    1823260-2026-01370
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQB
    UDI-DI
    04015630916511
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS 6000 C501 MODULE SERIAL NUMBER IS (B)(6). THE CALIBRATION DATA PROVIDED WAS PASSING ON THE DATE OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZAS RESULTS FROM THE COBAS 6000 C501 MODULE. RESULTS WERE PROVIDED FOR 3 PATIENT'S AS EXAMPLES. PATIENT 1'S INITIAL RESULT WAS 87 U/L, ACCOMPANIED BY A DATA FLAG. THE AUTOMATIC REPEAT RESULT WAS 31 U/L. PATIENT 2'S INITIAL RESULT WAS APPROXIMATED TO BE 90 U/L OR 100 U/L, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 12 U/L. PATIENT 3'S INITIAL RESULT WAS APPROXIMATED TO BE 80 U/L, AND THE REPEAT RESULT WAS 25 U/L. PATIENT 4'S INITIAL RESULT WAS APPROXIMATED TO BE 70 U/L, WITH A REPEAT RESULT OF 10 U/L. THE CUSTOMER ALLEGED THAT RERUN VALUES ARE NOT ALWAYS IN AGREEMENT WITH THE PATIENT'S PREVIOUS HISTORICAL RESULTS OR CLINICAL HISTORY (NORMAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890323 GAMMA-GLUTAMYLTRANSFERASE VER.2 - STANDARDIZED AGAINST SZAS GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM JQB ROCHE DIAGNOSTICS 93421901,92316701 04015630916511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown