BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1021832 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00412
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT WHILE PRIMING HER INFUSION SET SHE NOTICED INSULIN LEAKING FROM THE LUER LOCK. SHE STATED THAT SHE SAW A SMALL AMOUNT OF INSULIN POOLED BETWEEN THE ADAPTER AND THE LUER LOCK. SHE STATED THAT BOTH THE ADAPTER AND LUER CONNECTIONS SEEMED TO BE LOOSE. SHE STATED THAT THE ADAPTER WAS A "FEW" WEEKS OLD. THE PT WAS ADVISED TO ATTACH A NEW INFUSION TUBING, AND SHE WAS ABLE TO PRIME SUCCESSFULLY. NO INSULIN LEAKED FROM THE NEW INFUSION TUBING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WAS REQUESTED TO BE RETURNED FOR EVAL.

    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, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP