BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 3011843 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00418
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 27, 2013
    Report Date
    August 6, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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

    A VISUAL INSPECTION AND A TEST FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED SAMPLE. THE TUBING WAS DETACHED FROM THE LUER LOCK RESERVOIR CONNECTOR. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK AND STATIC PULL OF TUBING-LUER LOCK CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT ON THE MORNING OF (B)(6) 2013 THE PATIENT'S INFUSION SET WAS BROKEN WHERE THE TUBING CONNECTS TO THE LUER LOCK. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 16 MMOL/L (288 MG/DL). THE INFUSION SET WAS CHANGED AND THE PATIENT DID NOT EXPERIENCE ANY FURTHER PROBLEMS. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114558 ACCU-CHEK FLEXLINK INSULIN INFUSION SET LZG UNOMEDICAL DEVICES S.A. DE C.V. 00700006963 5506063

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR