BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUCHEK LLM

    MDR report key: 81609 · Received April 4, 1997

    Report

    Report Number
    1823260-1997-00025
    Event Type
    Injury
    Date Received
    April 4, 1997
    Date of Event
    February 27, 1997
    Report Date
    February 27, 1997
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    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

    DEVICE RESULTS DID NOT COMPARE TO LAB RESULTS ON PATIENT. STRIPS WERE ALLEGED TO BE "BLACK" AFTER USE. THE PATIENT HAD BEEN SENT HOME AFTER DEVICE READING AND WAS CONTACTED WHEN LAB RESULTS WERE RECEIVED. PATIENT WAS TOLD BY DOCTOR OF THE NEED FOR TREATMENT DAILY CONTROLS TESTED WITHIN RANGE. PATIENT PRESENTED WITH SEVERE DEHYDRATION, PER LABELING, "...READINGS MAY BE LOWER THAN TRUE CONCENTRATIONS IN HYPERGLYCEMIC-HYPEROSMOLAR STATE, WITH OR WITHOUT KETOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHEK LLM BLOOD GLUCOSE MONITORING DEVICE CFR BOEHRINGER MANNHEIM CORP. 796(METER) 252259(STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R