BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT

    MDR report key: 2337624 · Received November 15, 2011

    Report

    Report Number
    2050012-2011-07631
    Event Type
    Malfunction
    Date Received
    November 15, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JPZ
    PMA / PMN Number
    K971333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 STATING THAT WHEN THEY SWITCHED TO GGT LOT M103353 ON (B)(6) 2011 FOR A UNICEL DXC 800 SYNCHRON SYSTEM, THEIR QC SHIFTED HIGH. CUSTOMER RAN A PATIENT STUDY AND THE PATIENT RESULTS SHIFTED HIGH AS WELL. CUSTOMER HAD RECEIVED A NEW LOT M105340 AND THEIR QC RUNS WERE ACCEPTABLE AGAIN. CUSTOMER REPORTED THAT THEY WILL USE LOT M105340 FOR RUNNING PATIENT SAMPLES. ERRONEOUS PATIENT RESULTS GENERATED DURING THE STUDY WAS NOT REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® SYSTEMS GAMMA-GLUTAMYL TRANSFERASE (GGT) REAGENT COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE JPZ BECKMAN COULTER INC. GGT REAGENT M103353

    Patients

    Seq Age Sex Outcome Treatment
    1