BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1030578 · Received April 15, 2008

    Report

    Report Number
    2183996-2008-00530
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 7, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT'S FATHER REPORTED THE PT HAS ON 3 OCCASIONS WITHIN THE LAST WEEK RECEIVED AN ERROR NOTICE ON HIS INSULIN INFUSION DEVICE (COMPETITOR PRODUCT). THE PT'S FATHER STATED THE PT'S INFUSIONS SETS AT ISSUE HAVE OCCLUDED WITHIN THE FIRST 10 HOURS OF USE AND THEY ARE ALL FROM THE SAME LOT. HE STATED THE INFUSION SETS WERE DISCARDED. HE SAID THE PT ROTATES SITES REGULARLY ACROSS HIS THIGHS AND ABDOMEN. THE PT WAS SENT A GUIDE TO INFUSION SITE MGMT AND REPLACEMENT INFUSIONS SETS. ON FOLLOW UP, THE PT'S FATHER STATED THAT PT IS DOING WELL NOW. NO PHYSIOLOGICAL EFFECT WAS REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 588680

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN