BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2896361 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01930
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    December 1, 2012
    Report Date
    March 13, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR EVALUATION ON (B)(4) 2013. THE COMPLAINT DESCRIBING A LEAK ON THE HEADSET CANNOT BE VERIFIED; THE HEADSET MEETS PRODUCT SPECIFICATIONS. TWO RETURNED OPENED SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. ALL TEST RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT REPORTED THE INFUSION HEADSETS LEAKED INSULIN 3 TIMES WHEN BOLUSING ON (B)(6) 2012. HE NOTICED THE ISSUE WHEN HIS SHIRT AND THE ADHESIVE BECAME WET WITH INSULIN. ONE CANNULA WAS BENT AFTER THE HEADSET WAS REMOVED. AN INSERTION DEVICE IS USED TO INSERT THE HEADSETS. HE PRACTICES SITE ROTATION USING HIS STOMACH AND SIDES. HE DOES HEAR AN AUDIBLE CLICK WHEN THE TUBE IS ATTACHED TO THE HEADSET. THE INFUSION SETS WERE REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT 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 FPA ROCHE INSULIN DELIVERY SYSTEMS INC NA 212418

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP