BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1163423 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01369
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008 THE PATIENT REPORTED THAT HIS INFUSION DEVICE KEEPS RESTARTING. HE CHANGED THE BATTERY AND THE INFUSION DEVICE WOULD NOT TURN ON. HE CHANGED THE BATTERY AGAIN AND THE INFUSION DEVICE DISPLAYED THE LOW BATTERY ALERT. HE WAS ADVISED TO USE A NEW BATTERY COVER. UPON FOLLOW UP ON (B)(6) 2008 THE PATIENT STATED THAT HE REPLACED THE BATTERY AND BATTERY COVER AND THE INFUSION DEVICE IS BEEPING WITH BLACK LINES ACROSS THE DISPLAY. HE SWITCHED TO HIS BACKUP INFUSION DEVICE. 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 28 YR INSULIN| INSULIN INFUSION SET