BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2190613 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02130
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT SHE HAS EXPERIENCED HYPERGLYCEMIA IN THE 200-400 MG/DL RANGE OVER THE PAST 6 DAYS. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. PT SWITCHED TO A DIFFERENT TYPE OF INFUSION SET 6 DAYS AGO AND HAS BEEN INSERTING THE HEADSETS "SLOWLY" BY HAND. PT WAS ADVISED ON PROPER INSERTION TECHNIQUE. PT EXPERIENCED INSULIN LEAKAGE AT HER INFUSION SITE, AND WHEN SHE REMOVED THE HEADSET, SHE FOUND THE CANNULA WAS BENT. TIME, DATE, AND BASAL RATE PROFILE ARE PROGRAMMED CORRECTLY ON THE INFUSION DEVICE. PT DID NOT FORGET TO BOLUS. NORMAL BLOOD GLUCOSE IS 150 MG/DL, AND PT HAS TREATED HYPERGLYCEMIA WITH CORRECTION BOLUSES. INFUSION SET WAS DISCARDED AND IS NOT AVAILABLE TO RETURN FOR EVAL. PT WAS UNABLE TO PROVIDE INFUSION SET LOT OR EXPIRATION DATE. FOLLOW-UP WAS COMPLETED WITH PT ON (B)(6) 2011. PT MET WITH HER PHYSICIAN, AND PHYSICIAN INSERTED THE HEADSET FOR THE PT TO ENSURE IT WAS INSERTED CORRECTLY. SINCE PHYSICIAN INSERTED THE HEADSET, PT'S BLOOD GLUCOSE HAS RETURNED TO NORMAL. PT DID NOT REQUIRE TREATMENT FROM HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR INSULIN| INSULIN INFUSION DEVICE