BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1120943 · Received August 13, 2008

    Report

    Report Number
    2183996-2008-01211
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT FOR THE PAST 5 MINUTES HER INSULIN INFUSION DEVICE KEEPS SHUTTING OFF AND THEN BACK ON. SHE STATED, THE DEVICE WAS DROPPED WHEN IT STARTED HAPPENING. SHE SAID THE DEVICE HAS NO PHYSICAL DAMAGE. SHE TRIED REMOVING AND REINSERTING THE BATTERY BUT THE ISSUE HAS CONTINUED. SHE WILL SWITCH TO HER BACKUP INFUSION DEVICE. 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| INSULIN INFUSION SET