BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2896226 · Received December 7, 2012

    Report

    Report Number
    2183996-2012-01945
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 14, 2012
    Report Date
    March 11, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAKAGE, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED 7-8 INFUSION SETS FROM THE SAME LOT LEAKED INSULIN OVER THE PAST 2 WEEKS. HE DISCOVERED THE LEAKS DUE TO ELEVATED BLOOD GLUCOSE, BY SMELLING INSULIN, OR WHEN HIS CLOTHES BECAME WET WITH INSULIN. HIS BLOOD GLUCOSE WAS ELEVATED ON THE DAY OF THE REPORT, AND HE NOTICED WETNESS AROUND THE HARD PLASTIC PIECE OF THE INFUSION HEADSET. THE HEADSETS ARE INSERTED IN HIS ABDOMEN WITH AN INSERTION DEVICE. HE PRACTICES SITE ROTATION AND HEARS AN AUDIBLE CLICK WHEN THE HEADSET IS CONNECTED TO THE TUBE. THE INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. FOLLOW-UP WAS COMPLETED WITH THE PATIENT. HE REPORTED HIS BLOOD GLUCOSE ELEVATED AS HIGH AS 482 MG/DL, AND HIS NORMAL RANGE IS BELOW 200 MG/DL. HE WAS ABLE TO TREAT HYPERGLYCEMIA WITH INSULIN INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 0234016

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR INSULIN| INSULIN INFUSION PUMP AND RELATED ACCESSORIES| DATE OF THERAPY: UNK