BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2800068 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01593
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    August 27, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIBING A LEAK AT THE HEAD SET CONNECTION CANNOT BE VERIFIED, THE TRANSFER SETS MEET PRODUCT SPECIFICATIONS. A VISUAL INSPECTION AND TESTS FOR FLOW, LEAK AND CLICK WERE PERFORMED ON THE RETURNED USED DEVICES. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND CLICK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION SETS HAVE LEAKED INSULIN AT THE CONNECTOR FOR THE PAST 6 WEEKS. HER BLOOD GLUCOSE HAS ELEVATED ABOVE 500 MG/DL AS A RESULT. THE INFUSION SETS ARE INSERTED MANUALLY, AND THE HEADSET IS CHANGED EVERY 2 DAYS AND THE TUBE EVERY 4 DAYS. SHE DID NOT HAVE AN INFECTION OR START NEW MEDICATION. THE INFUSION SETS WERE REQUESTED FOR EVAL. SHE 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 FLEXLINK FPA ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006964 223581

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP