BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CREATININE PLUS SYSTEM PACK

    MDR report key: 118827 · Received September 8, 1997

    Report

    Report Number
    1823260-1997-00075
    Event Type
    Injury
    Date Received
    September 8, 1997
    Date of Event
    July 26, 1997
    Report Date
    July 26, 1997
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CGL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CANCER PATIENT WITH UNSPECIFIED "ILLNESS" WAS HOSPITALIZED BASED ON A CREATININE RESULT OF 13.8 MG/DL FROM THE SUSPECT DEVICE. THE FOLLOWING DAY, AN ALTERNATE METHOD (JAFFE REACTION) WAS USED TO ASSAY THE SAMPLE WITH A RESULT OF 2.0 MG/DL. THE TREATING PHYSICIAN BELIEVED THE 2.0 MG/DL VALUE BETTER FIT THE PATIENT'S CONDITION. THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF BLOOD, BUT THE REPORTING TECHNICIAN DID NOT KNOW IF THIS WAS BEFORE OR AFTER THE CREATININE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CREATININE PLUS SYSTEM PACK CREATININE REAGENT CGL BOEHRINGER MANNHEIM CORP. R1/R2 67848101/67846201

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization