BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1120958 · Received August 13, 2008

    Report

    Report Number
    2183996-2008-01201
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT OVER THE WEEKEND THE DISPLAY OF HER INSULIN INFUSION DEVICE WAS BLANK AND SHE COULD NOT SEE HER BOLUS HISTORY. SHE SAID IT STAYED THAT WAY FOR 2 DAYS BUT STARTED WORKING AGAIN TODAY. SHE STATED THE DISPLAY IS NOT CRACKED BUT "LOOKED SHATTERED TO WHERE I COULD NOT READ IT." THE PATIENT STATED HER INFUSION DEVICE HAS BEEN EXPOSED TO EXTREME HEAT AS HER HOME GETS AS WARM AS 115 DEGREES. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN