BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCU-CHEK FLEXLINK

    MDR report key: 2943326 · Received January 21, 2013

    Report

    Report Number
    2183996-2012-02160
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 18, 2012
    Report Date
    April 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
    UK
    Reporter Occupation
    NOT APPLICABLE

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER. THE RESPONSIBLE QUALITY DEPARTMENT HAS PERFORMED AN INVESTIGATION IN ATTEMPT TO IDENTIFY ANY MALFUNCTIONS RELATED TO CRACKED TUBING. A VISUAL INSPECTION AND A TEST FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED TRANSFER SET. THE TUBING WAS SPLIT FROM THE LUER LOCK CONNECTOR, AND THE TUBING WAS LEAKING. THE LOT NUMBER IS UNKNOWN, SO THE RETENTION SAMPLE COULD NOT BE INVESTIGATED. THE MANUFACTURER TESTS THE PRODUCTS DURING PRODUCTION FOR LEAKS AND FLOW. THERE IS NO INDICATION THAT A NONSPECIFIC PRODUCT HAS BEEN DELIVERED TO THE CUSTOMER.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION TUBE BROKE AWAY FROM THE LUER LOCK AFTER THE INFUSION SET HAD BEEN IN USE FOR 1 DAY. HE HAS NOT EXPERIENCED THIS CONCERN WITH OTHER INFUSION SETS AND WAS UNABLE TO PROVIDE THE LOT OR EXPIRATION DATE. THE INFUSION SET WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28989 INCU-CHEK FLEXLINK FPA ROCHE HEALTH SOLUTIONS INC. 00700006964 UNK

    Patients

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