BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1413686 · Received July 9, 2009

    Report

    Report Number
    2183996-2009-01356
    Event Type
    Injury
    Date Received
    July 9, 2009
    Date of Event
    June 6, 2009
    Report Date
    June 9, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2009 THE PT'S FATHER CALLED WITH QUESTIONS CONCERNING THE PT INFUSION SETS. HE THEN REPORTED THAT THE PT HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE OF 600 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-130 MG/DL. THE PT'S INSULIN CARTRIDGE, INFUSION SITE, AND TUBING WERE CHANGED AS WELL AS THE INFUSION SITE LOCATION. THE INFUSION TUBING WAS PRIMED UNTIL INSULIN FLOWED FROM THE END AND THERE WERE NO AIR BUBBLES IN THE SYSTEM. THERE WERE NO INSULIN LEAKS AND THE INFUSION DEVICE (COMPETITOR PRODUCT) DID NOT DISPLAY ANY ERROR MESSAGES. THE PT WAS SPILLING KETONE AND SHE WAS TAKEN TO THE HOSPITAL IN 2009, AND RELEASED AFTER A FEW HOURS. SHE WAS TREATED WITH AN IV AND INJECTIONS THERAPY. HER INFUSION DEVICE IS BEING REPLACED. AT THE TIME OF THE REPORT HER BLOOD GLUCOSE MEASURED 250-264 MG/DL. FURTHER ATTEMPTS TO FOLLOW UP WITH PT WERE UNSUCCESSFUL. 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 03/01/2013

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| O| R INSULIN INFUSION PUMP| INSULIN