BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPID D INFUSION SET

    MDR report key: 1033710 · Received April 25, 2008

    Report

    Report Number
    2183996-2008-00583
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 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
    VA, 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 THAT SHE RECEIVED AN E4 (OCCLUSION) ERROR WHILE ATTEMPTING TO BOLUS FOR ELEVATED BLOOD GLUCOSE. SHE CLEARED THE ERROR AND WAS THEN INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE. SHE WAS INSTRUCTED TO PERFORM A PRIME AND SHE RECEIVED AN E4. SHE WAS THEN INSTRUCTED TO REMOVE THE INFUSION TUBING FROM THE INFUSION DEVICE AND SHE WAS ABLE TO PRIME THROUGH THE ADAPTER WITHOUT ERROR. SHE WAS ADVISED TO CHANGE HER INFUSION TUBING. SHE STATED THAT THE INFUSION TUBING HAD BEEN IN USE FOR "ABOUT A WEEK." SHE WAS ADVISED TO CHANGE THE INFUSION TUBING EVERY 6 DAYS. THE PT'S BLOOD GLUCOSE MEASURED 185 MG/DL AT 5:17AM AND 215 MG/DL AT 6:00AM. AT 9:08MG/DL HER BLOOD GLUCOSE WAS ELEVATED TO 452MG/DL. SHE STATED THAT ELEVATED BLOOD GLUCOSE WAS DUE TO "EATING BREAKFAST WITH NO INSULIN." DURING THE REPORT THE PT BOLUSED A "FEW" UNITS OF INSULIN TO LOWER HER BLOOD GLUCOSE. UPON FOLLOW UP ON TWO DAYS LATER, THE PT STATED HER BLOOD GLUCOSE READINGS ARE NORMALLY ERRATIC BECAUSE SHE IS A BRITTLE DIABETIC. SHE FEELS HER PRODUCT IS FUNCTIONING PROPERLY. THE PT DID NOT REQUIRE MEDICAL 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 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