BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081700 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-01010
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1483-2011
    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

    THE PATIENT REPORTED EXPERIENCING INSULIN LEAKAGE, E4 (OCCLUSION) ERRORS, AND BENT CANNULAS WHILE USING THE INFUSION SETS. SHE STATED SHE WAS ABLE TO SMELL INSULIN AND SEE IT ON HER CLOTHING. OCCLUSIONS OCCURRED ON 2 OCCASIONS. SHE STATED SHE WOULD SOMETIMES EXPERIENCE PAIN WHILE BOLUSING AND BELIEVED IT MAY HAVE BEEN DUE TO A BENT CANNULA. THE PATIENT USED THE INSERTION DEVICE TO INSERT THE HEADSET. NO FURTHER INFORMATION IS AVAILABLE. 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 PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA GWX115

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN