BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA-GLUTAMYLTRANSFERASE (GGT)

    MDR report key: 19819604 · Received July 24, 2024

    Report

    Report Number
    1823260-2024-02146
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 3, 2024
    Report Date
    December 19, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQB
    UDI-DI
    07613336121252
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    C503 ANALYZER A SERIAL NUMBER WAS (B)(6). THE SERIAL NUMBER FOR C503 ANALYZER B WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CALIBRATION WAS ACCEPTABLE. THE CUSTOMER STATED QC WAS ACCEPTABLE. MULTIPLE "ABNORMAL ASPIRATION" AND "SAMPLE SHORT" ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. THE ANALYZER WAS INSPECTED AND CRYSTALLIZATION OF BASIC WASH SOLUTION WAS OBSERVED AROUND A MANIFOLD (LIKELY FROM A PREVIOUS LEAK IN (B)(6) 2024; NO CURRENT LEAKS WERE OBSERVED). SAMPLE AND REAGENT PROBES WERE REPLACED AND ADJUSTED, AND THE ULTRASONIC MIXER HEIGHT AND WATER SUPPLY WERE ADJUSTED. INSTRUMENT PERFORMANCE TESTING WAS ACCEPTABLE. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PREANALYTICAL HANDLING ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR GAMMA-GLUTAMYLTRANSFERASE (GGT) ON TWO COBAS C 503 ANALYTICAL UNITS. THE INITIAL RESULT WAS 91.4 UI/L ON C503 ANALYZER A. THE SAMPLE WAS REPEATED ON C503 ANALYZER A WITH RESULTS OF 55.6 UI/L, 57 UI/L, AND 66 UI/L. THE SAMPLE WAS REPEATED ON C503 ANALYZER B WITH A RESULT OF 91.4 UI/L ACCOMPANIED BY AN INVALIDATING DATA FLAG. THE REPEAT RESULTS ON C503 ANALYZER B WERE 91.4 UI/L AND 56 UI/L. THE RESULTS CLOSE TO 56 UI/L WERE BELIEVED TO BE CORRECT. ANOTHER SAMPLE FROM THE PATIENT WAS REPEATED 5 TIMES WITH RESULTS OF 51 UI/L AND 52 UI/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408640 GAMMA-GLUTAMYLTRANSFERASE (GGT) GAMMA-GLUTAMYL TRANSPEPTIDASE JQB ROCHE DIAGNOSTICS 794275 07613336121252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown