BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1231724 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01730
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HER INSULIN INFUSION SET DISCONNECTED FROM HER INFUSION DEVICE WHILE SHE WAS SLEEPING. SHE SAID SHE WOKE UP TO A BLOOD GLUCOSE READING OF 400 MG/DL WITH HER NORMAL RANGE BEING AROUND 100 MG/DL. NO PHYSICAL SYMPTOMS WERE REPORTED. SHE STATED SHE TREATED HER READING BY INJECTING 8 UNITS OF INSULIN BY SYRINGE. THE PT DID NOT HAVE THE LUER LOCK ON SECURELY AND STATED SHE PUSHED THE LUER LOCK ONTO THE CARTRIDGE. SHE WAS ADVISED TO TWIST THE LUER LOCK CLOCKWISE TO SECURELY FASTEN IT. THE PT WAS ABLE TO SUCCESSFULLY PRIME UNTIL INSULIN FLOWED FROM THE TUBING AND THEN RECONNECTED TO HER HEADSET. ON FOLLOW UP WITH THE PT, SHE STATED HER BLOOD GLUCOSE IS BACK TO HER NORMAL RANGE AND EVERYTHING IS FINE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION PUMP| INSULIN