BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUCHEK ADVANTAGE

    MDR report key: 184361 · Received August 26, 1998

    Report

    Report Number
    1823260-1998-00097
    Event Type
    Injury
    Date Received
    August 26, 1998
    Date of Event
    August 11, 1998
    Report Date
    August 14, 1998
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT HIS BLOOD GLUCOSES WERE "JUMPING AROUND A LOT" ON THE SUSPECT DEVICE. THE LAST READINGS IN MEMORY WERE 306, 161, 212. PATIENT WENT TO THE HOSPITAL AND WAS TREATED WITH AN INTRAVENOUS. NO OTHER INFORMATION COULD BE PROVIDED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS 553 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention