BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2182533 · Received July 19, 2011

    Report

    Report Number
    2183996-2011-02078
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 13, 2009
    Report Date
    July 13, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, WIFE REPORTED THAT PT EXPERIENCED ERRATIC BLOOD GLUCOSE WHILE USING THE INFUSION DEVICE DUE TO ABSORPTION ISSUES CAUSED BY SCAR TISSUE. PT DEVELOPED "HARD BUMPS" WHERE HIS INFUSION SITES WERE LOCATED. PHYSICIAN ORDERED HIM TO STOP USING THE INFUSION DEVICE BECAUSE, HE "DOES NOT BELIEVE IN INSULIN PUMPS," AND PT'S A1C BLOOD TEST WAS ELEVATED. BLOOD GLUCOSE WOULD ELEVATE TO 300-400 MG/DL IN THE MORNING AND WOULD OCCASIONALLY BE "VERY LOW" IN THE MIDDLE OF THE NIGHT. PT WOULD WAKE UP IN A SWEAT, AND WIFE WOULD TREAT HYPOGLYCEMIA WITH GLUCOSE. WIFE REPORTED THE BLOOD GLUCOSE METER WOULD READ "LO" WHEN THIS HAPPENED, AND SHE ALSO HAD TO CALL THE AMBULANCE. WIFE BELIEVES THE LAST TIME THIS OCCURRED WAS 2 YEARS AGO, AND PT RECEIVED A GLUCOSE IV TREATMENT FROM PARAMEDICS. PT'S TARGET BLOOD GLUCOSE IS 120 MG/DL. WIFE REPORTED BLOOD GLUCOSE CONTINUES TO FLUCTUATE WHILE ON INJECTION THERAPY, BUT IT IS NOT AS SEVERE. WIFE REPORTED THAT PHYSICIAN BELIEVES ERRATIC BLOOD GLUCOSE WAS DUE TO PT'S BODY AND THAT HE HAD DEVELOPED TOO MUCH SCAR TISSUE. NO PRODUCT MALFUNCTIONS WERE ALLEGED. INFUSION SETS WERE NOT AVAILABLE TO RETURN FOR EVALUATION OR TO PROVIDE PRODUCT INFORMATION.

    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 50 YR Required Intervention INSULIN INFUSION DEVICE| INSULIN