BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1944488 · Received December 28, 2010

    Report

    Report Number
    2183996-2010-02693
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    October 17, 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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE U.S. 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

    PT'S MOTHER REPORTED 2 MONTHS AGO, THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS OF UP TO 400 MG/DL. TREATMENT RECEIVED WAS NOT PROVIDED. MOTHER STATED THE DOCTOR THOUGHT THE PROBLEM WAS DUE TO THE INFUSION SET AND ADVISED THEM TO CHANGE IT COMPLETELY AND TO TAKE IT FROM DIFFERENT BOXES. MOTHER REPORTED THE ISSUE PERSISTED. MOTHER STATED ONCE THEY SUBSTITUTED THE INFUSION DEVICE WITH THE BACKUP INFUSION DEVICE AND THE BLOOD LEVELS RETURNED TO NORMAL. PT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. MOTHER REPORTED DURING THAT TIME, THE INFUSION DEVICE DID NOT GIVE ANY ERROR OR ALARM. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED 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 Required Intervention INSULIN INFUSION SET| INSULIN