BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1250014 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01725
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT SHE OFTEN EXPERIENCES OCCLUSION (E4) ERRORS DUE TO THE NEEDLE BETWEEN THE INFUSION TUBING AND HEADSET BENDING. SHE STATED THAT SHE DISCONNECTS FROM THE INFUSION TUBING ONCE PER DAY TO SHOWER AND SHE RECONNECTS PER THE INSTRUCTIONS FOR USE. SHE CHANGES THE INFUSION SITE EVERY 2 DAYS AND THE INFUSION TUBING EVERY 6 DAYS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUITE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PATIENT DISCARDED THE ALLEGED PRODUCT. NO PRODUCT WILL 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 356317

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR INSULIN INFUSION PUMP| INSULIN