BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA-GLUTAMYLTRANSFERASE VER.2

    MDR report key: 20384249 · Received October 7, 2024

    Report

    Report Number
    1823260-2024-02900
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 9, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQB
    UDI-DI
    04015630916511
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION RESULTS FROM (B)(6) 2024 AND (B)(6) 2024 WERE ACCEPTABLE. THE QC RECOVERIES WERE WITHIN THE +/-2 STANDARD DEVIATION RANGE. THE ALARM TRACE DID NOT CONTAIN A CONSPICUOUS EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ALARM TRACE SHOWED SEVERAL SAMPLE SHORT AND ABNORMAL PROBE SUCKING ALARMS. IT WAS FOUND THAT THE CUSTOMER DOES NOT CLEAN THE ANALYZER SAMPLE AND REAGENT PROBES DAILY AS INSTRUCTED IN THE OPERATOR'S MANUAL. BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GGT-2 ¿-GLUTAMYLTRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL GGT-2 RESULT WAS 4 U/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 26 U/L. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268419 GAMMA-GLUTAMYLTRANSFERASE VER.2 GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM JQB ROCHE DIAGNOSTICS 77885901 04015630916511

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown