BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2070369 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01090
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 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
    MT, 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 A CONCERN WITH BENT INFUSION CANNULAS. SHE DID NOT HAVE ADD'L INFO AND ASKED TO CALL BACK AT A LATER TIME. FOLLOW-UP WAS COMPLETED WITH PT ON (B)(6) 2011. PT EXPERIENCED ELEVATED BLOOD GLUCOSE IN THE 300 MG/DL RANGE. SHE WOULD REMOVE THE INFUSION HEADSET AND NOTICE THE CANNULA WAS BENT CLOSE TO THE ADHESIVE. THERE WAS ALSO INSULIN LEAKAGE FROM INSULIN POOLING UNDERNEATH HER SKIN. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. NORMAL BLOOD GLUCOSE IS 120-150 MG/DL. PT TREATED HYPERGLYCEMIA BY CHANGING THE HEADSET AND BOLUSING, AND BLOOD GLUCOSE WOULD THEN DECREASE. PT WAS NOT ABLE TO PROVIDE THE DATES THAT THIS OCCURRED, BUT THIS WAS AN ONGOING INTERMITTENT ISSUE. PT DID NOT HAVE SCAR TISSUE, INFECTION, OR IRRITATION AT HER INFUSION SITES. NO PRODUCT HAS REQUESTED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE FROM A 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 0H089UF

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR INSULIN| INSULIN INFUSION DEVICE