BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1942530 · Received December 22, 2010

    Report

    Report Number
    2183996-2010-02678
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 17, 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. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE DELIVERED INACCURATELY. PATIENT REPORTED EXPERIENCING AN ELEVATED BLOOD GLUCOSE LEVEL OF 400 MG/DL. PATIENT STATED SHE CHANGED THE INFUSION SET BUT HAD NO SUCCESS. PATIENT REPORTED SHE TOOK A CORRECTION WITH A PEN AND THEN HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL. PATIENT STATED WHEN SHE TOOK CORRECTION VIA THE INFUSION DEVICE, HER BLOOD GLUCOSE LEVEL SHOWED NO REACTION. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    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 Required Intervention INSULIN INFUSION SET| INSULIN