BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1953449 · Received December 30, 2010

    Report

    Report Number
    2183996-2010-02716
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED AFTER SHE CHANGES THE INSULIN CARTRIDGE, SHE ONLY NEEDS 80-90% OF THE INSULIN SHE USUALLY NEEDS. PATIENT STATED SHE HAS TO REDUCE HER BASAL RATES AND THEN AFTER 3 DAYS, SHE CAN CHANGE THE BASAL RATE BACK TO 100% AGAIN. PATIENT REPORTED IF SHE DOESN'T DO THIS, SHE EXPERIENCES HYPOGLYCEMIA AND HER BLOOD GLUCOSE DECREASES TO 3 MMOL/L (54 MG/DL). TREATMENT RECEIVED WAS NOT PROVIDED. PT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PT STATED SHE THINKS THE INFUSION DEVICE DELIVERS TOO MUCH INSULIN. PATIENT REPORTED SHE USED THE INSULIN CARTRIDGE FOR 10 DAYS. ADVISED PT ON RECOMMENDATION FOR CARTRIDGE USE. NO FURTHER INFO IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention INSULIN| INSULIN INFUSION SET