BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1193207 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01548
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 19, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT SHE RECEIVED AN A2 (LOW BATTERY) ALARM ON HER INFUSION DEVICE AND AFTER SHE CHANGED THE BATTERY SHE FOUND THAT THE BOLUS HISTORY HAD BEEN ERASED. SHE STATED THAT SHE HAD PROGRAMMED A BOLUS AND WAS NOT ABLE TO LOCATE THE BOLUS IN THE HISTORY AFTER THE BATTERY WAS CHANGED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL 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 33 YR INSULIN INFUSION SET| INSULIN