BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2070431 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01100
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED, THE INFUSION SET IS LEAKING. PATIENT STATED THE ISSUE OCCURRED A COUPLE OF DAYS AFTER INSERTING. PATIENT REPORTED FEELING DAMPNESS WHEN INSULIN LEAKED TO THE CLOTHING. PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS UP TO 10 MMOL/L (180 MG/DL) AFTER THE INFUSION SET WAS IN A COUPLE OF DAYS. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PATIENT STATED, THE LUER LOCK WAS NOT SECURE BETWEEN THE INFUSION SET TUBING AND THE INFUSION SET CANNULA. PATIENT REPORTED, THE LUER LOCK HAS DETACHED. PATIENT USES THE INSERTION ASSIST PLUS DEVICE TO INSERT THE INFUSION SETS. PATIENT STATED, THE ISSUE FIRST OCCURRED A COUPLE OF MONTHS AGO AND HAS HAPPENED 40% OF THE TIME. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN