BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 315422 · Received February 5, 2001

    Report

    Report Number
    1823260-2001-00016
    Event Type
    Malfunction
    Date Received
    February 5, 2001
    Date of Event
    December 15, 2000
    Report Date
    December 15, 2000
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SUSPECT DEVICE WAS USED TO CHECK THEIR BLOOD GLUCOSE AND A RESULT OF 929MG/DL WAS OBTAINED. THE PT CALLED A NURSE WHO SAID THE DEVICE WAS PROBABLY WRONG AND ADVISED THE PT TO RETEST EVERY THIRTY MINUTES. THE NURSE ALSO ADVISED THE PT TO EAT. THE CUSTOMER DID NOT SHOW SYMPTOMS OF HYPERGLYCEMIA. REPEAT RESULTS WERE 122, 112, 147 AND 140MG/DL. THE CUSTOMER DID NOT RECEIVE ANY MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4242 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE CGA ROCHE DIAGNOSTICS 2138930 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR