BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2781867 · Received October 5, 2012

    Report

    Report Number
    2183996-2012-01515
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    June 27, 2012
    Report Date
    March 27, 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. 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 REFERENCE SAMPLES WERE ANALYZED AGAINST THE CUSTOMER'S ALLEGATION. THE COMPLAINT DESCRIBING A LEAKY 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. NO PRODUCT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT NOTICED THAT THE SELF-ADHESIVE ON HIS INFUSION SET WAS WET ON SEVERAL OCCASIONS. THE PT HAS BEEN EXPERIENCING THIS PROBLEM FOR THREE MONTHS. HIS BLOOD GLUCOSE LEVELS HAVE BEEN ELEVATED AS HIGH AS 550 MG/DL. HE HAS BEEN ABLE TO CORRECT THE ELEVATED LEVELS HIMSELF. HE THINKS THERE IS A LEAK BETWEEN THE CANNULA AND SELF-ADHESIVE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE 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 216708

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR INSULIN INFUSION PUMP| ACCESSORIES| INSULIN