BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2800150 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01560
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 27, 2012
    Report Date
    March 20, 2013
    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. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REFERENCE SAMPLES WERE ANALYZED AGAINST THE CUSTOMER'S ALLEGATION. THE COMPLAINT DESCRIBING A LEAK ON THE HEAD SET CANNOT BE VERIFIED, THE HEAD SET MEETS PRODUCT SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON SEVERAL OCCASIONS OVER THE PAST 3 MONTHS THE SELF-ADHESIVE OF THE INFUSION SET HEADSET HAS BEEN WET. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF UP TO 550 MG/DL. ON (B)(6) 2012 AT 7:30 AM HIS BLOOD GLUCOSE MEASURED 120 MG/DL AND HE ATE 3 BE AND ADMINISTERED 6 I.U. VIA THE INFUSION DEVICE. AT 2:30PM HIS BLOOD GLUCOSE MEASURED 550 MG/DL AND HE FOUND THE SELF-ADHESIVE WAS WET. HE BELIEVES THERE IS A LEAK BETWEEN THE SOFT-CANNULA AND THE SELF-ADHESIVE. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK FPA ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006960 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR DATE OF THERAPY: UNK| INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN