BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1295108 · Received January 22, 2009

    Report

    Report Number
    2183996-2008-02100
    Event Type
    Injury
    Date Received
    January 22, 2009
    Date of Event
    December 23, 2008
    Report Date
    December 24, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETUNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN LATE 2008, THE PATIENT'S HUSBAND REPORTED THE PATIENT'S BLOOD GLUCOSE READINGS YESTERDAY WERE SLIGHTLY ELEVATED BUT SHE WAS ABLE TO DECREASE IT TO HER TARGET RANGE OF 100-125 MG/DL. THIS MORNING SHE WOKE UP WITH A READING OF 125 MG/DL AND AT 1 PM HER READING WAS IN THE HIGH 200'S MG/DL. AT 3:30 PM IT WAS 420 MG/DL AND SHE BOLUSED 12.4 UNITS OF INSULIN. AT 5:20 PM HER READING WAS 290 MG/DL WHEN SHE DECIDED TO CALL FOR ASSISTANCE TO CHANGE THE INSULIN CARTRIDGE OF HER INFUSION DEVICE. THE PATIENT AND HER HUSBAND WAS ASSISTED WITH PROPERLY CHANGING THE INSULIN CARTRIDGE AND PRIMING THE INFUSION SET. HER HUSBAND STATED THE PATIENT MAY HAVE HAD "HOLIDAY SWEETS" FOR WHICH SHE DIDN'T BOLUS BUT SHE COULD NOT REMEMBER. THE BOLUS HISTORY ON HER DEVICE WAS CHECKED AND SHOWED 2 BOLUSES FOR THE DAY. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS 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 54 YR Required Intervention INSULIN| INSULIN INFUSION SET