BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1202823 · Received October 14, 2008

    Report

    Report Number
    2183996-2008-01581
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HE AWOKE THIS MORNING WITH AN ELEVATED BLOOD GLUCOSE READING OF 299 MG/DL WHICH HAS NOW INCREASED TO 360 MG/DL. HE SAID HIS NORMAL RANGE IS 70-80 MG/DL FOR THIS TIME OF DAY. THE PT STATED THAT WHEN HE LOOKED AT HIS INSULIN INFUSION DEVICE, HE NOTICED THE BATTERY COVER HAD COME OFF DURING THE NIGHT AND THE BATTERY FELL OUT OF THE DEVICE CAUSING AN INTERRUPTION IN THE INSULIN DELIVERY. HE SAID HE TREATED HIS ELEVATED READINGS BY GIVING HIMSELF A BOLUS OF INSULIN. THE PT STATED HE HAS NEVER CHANGED THE DEVICE BATTERY COVER. HE WAS ADVISED THE BATTERY COVER SHOULD BE CHANGED WITH EVERY 4TH BATTERY CHANGE. THE PT WAS SENT COURTESY BATTERY COVERS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    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 Required Intervention INSULIN| INSULIN INFUSION SET