BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1911282 · Received November 23, 2010

    Report

    Report Number
    2183996-2010-02472
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 18, 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

    THE PT REPORTED EXPERIENCING UNEXPLAINABLE ELEVATED BLOOD GLUCOSE OF UP TO 526 MG/DL SINCE (B)(6) 2010. THE PT WOULD CHANGE THE INFUSION SET AND BOLUS THROUGH THE INFUSION DEVICE TO LOWER HER BLOOD GLUCOSE. ON (B)(6) 2010, THE PT'S BLOOD GLUCOSE MEASURED 86 MG/DL IN THE EVENING AND SHE ATE 1 BE. ON (B)(6) 2010, HER BLOOD GLUCOSE MEASURED 309 MG/DL IN THE MORNING AND SHE INJECTED INSULIN VIA SYRINGE. HER NORMAL BLOOD GLUCOSE RANGE IS 100-120 MG/DL. THE PT QUESTIONS THE ACCURACY OF INSULIN DELIVERY. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention INSULIN| INSULIN INFUSION SET