BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2253732 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02235
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 7, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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

    PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS ON (B)(6) 2011 - (B)(6) 2011 OF 350 MG/DL AND 420 MG/DL. PT NORMAL BLOOD GLUCOSE RANGE IS 80-100 MG/DL. PT STATED, SHE CHANGED THE INFUSION SET 4 TIMES AND CORRECTED VIA THE INFUSION DEVICE AND PEN. PT REPORTED ON (B)(6) 2011 SHE SWITCHED TO THE BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL. PT STATED, SHE WAS ABLE TO GET HER BLOOD GLUCOSE LEVEL UNDER CONTROL BY HERSELF. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 INSULIN| INSULIN INFUSION SET