BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1082383 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01108
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT DURING A BOLUS SHE RECEIVED AN E4 (OCCLUSION) MESSAGE ON HER INSULIN INFUSION DEVICE. SHE STATED SHE CHANGED THE INSULIN AND INFUSION SET TUBING, PRIMED, AND RECEIVED ANOTHER OCCLUSION MESSAGE. SHE STATED SHE CHANGES HER INFUSION HEADSET EVERY 48 HOURS AND THE TUBING EVERY 6 DAYS. TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO DETACH THE TUBING FROM HER INFUSION DEVICE AND PRIME THROUGH THE ADAPTER WHICH WENT THROUGH WITHOUT ERROR. SHE WAS INSTRUCTED TO REATTACH THE TUBING AND PRIME AND SHE AGAIN RECEIVED AN OCCLUSION MESSAGE. SHE STATED BOTH TUBINGS WERE FROM THE SAME BOX. SHE SAID SHE DISCARDED THE FIRST TUBING BUT WOULD RETURN THE SECOND TUBING. THE PATIENT THEN TRIED A THIRD TUBING AND PRIMED WITHOUT ERROR. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 142347

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN