BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2210188 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01975
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 28, 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 THE INSULIN DELIVERY OF THE INFUSION DEVICE HAS BEEN TOO LOW SINCE (B)(6) 2011. BLOOD GLUCOSE ELEVATED ABOVE 500 MG/DL ON (B)(6) 2011 AT 9:05 A.M. PT DELIVERED INSULIN VIA SYRINGE AND WAS ABLE TO CONTROL BLOOD GLUCOSE BY HERSELF, AND SHE SAW HER DIET COUNSELOR ON (B)(6) 2011. INFUSION NEEDLE AND TUBE ARE CHANGED EVERY 3 DAYS, AND PT WAS REFERRED TO THE USER GUIDE. NORMAL FASTING BLOOD GLUCOSE IS 80-140 MG/DL AND POSTPRANDIAL BLOOD GLUCOSE IS 180 MG/DL. INFUSION DEVICE WAS NOT EXPOSED TO ELECTROMAGNETIC FIELDS OR WATER. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    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 31 YR INSULIN INFUSION SET| INSULIN