BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2982055 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00181
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 30, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIBING A LEAK AT THE HEADSET CONNECTION CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER. A VISUAL INSPECTION AND A TEST FOR FLOW, LEAK, AND STATIC PULL WERE PERFORMED ON THE RETURNED USED TRANSFER SET. THE TUBING WAS DETACHED FROM THE CONNECTOR, AND THIS RESULTED IN LEAKING. THE FLOW TEST WAS IN ACCORDANCE WITH SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW, LEAK, AND STATIC PULL, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH FOR LOT # 5002948 WAS VERIFIED AND FOUND WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION SET LEAKED INSULIN NEAR THE CONNECTOR AND THIS CAUSED HYPERGLYCEMIA. HIS BLOOD GLUCOSE WAS AROUND 6 MMOL/L (252 MG/DL) AFTER LUNCH AND 16 MMOI/L (288 MG/DL) AND HOUR LATER. HE CHECKED THE INFUSION SET AND FOUND THE CONNECTION WAS LOOSE. HE DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55248 ACCU-CHEK FLEXLINK FPA ROCHE HEALTH SOLUTIONS INC. 00700006964 5002948

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN