BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1192452 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01527
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 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
    OH, US
    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 AN ELEVATED BLOOD GLUCOSE READING OF 298 MG/DL. SHE SAID, SHE DOES NOT HAVE A NORMAL BLOOD GLUCOSE RANGE. SHE STATED SHE NORMALLY CHANGES HER INSULIN INFUSION HEADSET EVERY 3 DAYS AND HER CURRENT HEADSET HAS BEEN IN USE FOR OVER 48 HOURS. THE PT WAS ADVISED TO CHANGE HER INFUSION HEADSET VERY 2 DAYS AND HER TUBING EVERY 6 DAYS. DURING TROUBLESHOOTING, THE PT STATED THERE WAS "NOTHING UNUSUAL AT THE SITE." SHE SAID, SHE HAS USED 3 INFUSION SETS FROM HER CURRENT BOX AND BELIEVES IT IS THE INFUSION SETS. SHE SAID, SHE DID NOT KEEP ANY OF THE INFUSION SETS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED. NO PRODUCT WAS AVAILABLE 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 NA 216357

    Patients

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