BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1911396 · Received November 24, 2010

    Report

    Report Number
    2183996-2010-02437
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 10, 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

    PT REPORTED, THE INFUSION DEVICE DELIVERS INACCURATELY. PT STATED, THE CAUSE IS UNK AND THE INFUSION DEVICE DISPLAYED NO ERROR ALERT. PT REPORTED CHANGING THE INFUSION SET WITH NO SUCCESS. PT REPORTED, A BLOOD GLUCOSE LEVEL OF 309 MG/DL; TOOK CORRECTION VIA PEN. PT'S NORMAL BLOOD GLUCOSE LEVEL IS 100-140 MG/DL. PT REPORTED BEING IN THE HOSPITAL SINCE (B)(6) 2010; TREATMENT RECEIVED WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. 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 Hospitalization| R INSULIN| INSULIN INFUSION SET