BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1911397 · Received November 24, 2010

    Report

    Report Number
    2183996-2010-02439
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 9, 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 VOMITING AND FEELING VERY SICK ON (B)(6) 2010 AT 3:10AM AND THEN HE CALLED THE EMERGENCY DOCTOR. PT STATED AT 4:10 AM, HE WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. PT REPORTED, HIS BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. NO NORMAL BLOOD GLUCOSE RANGE WAS PROVIDED. PT STATED, HE AND THE DOCTOR FEEL, THE INFUSION DEVICE WILL NOT DELIVER THE BOLUS CORRECTLY. TREATMENT RECEIVED AND LENGTH OF STAY WAS NOT PROVIDED. PT REPORTED, HE IS CURRENTLY FINE. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 39 YR Hospitalization| R INSULIN INFUSION SET| INSULIN