BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1071405 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-00993
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED RECEIVING SEVERAL E4 (OCCLUSION) ERRORS AT 4:00 AM. HE STATED THAT HE CLEARED THE ERROR EACH TIME, BUT HE DID NOT CHANGE THE INFUSION TUBING OR INFUSION SITE. THE INFUSION TUBING HAD BEEN IN USE FOR 4 DAYS AND THE INFUSION SITE HAD BEEN IN USE FOR 1.5 DAYS. BY 7:30 AM HIS BLOOD GLUCOSE WAS ELEVATED TO 300 MG/DL AND HE BOLUSED VIA SYRINGE. HIS NORMAL BLOOD GLUCOSE RANGE IS 80-110 MG/DL. TO TROUBLESHOOT, HE WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO PERFORM A PRIME. HE REC'D AN E4 ERROR. HE WAS INSTRUCTED TO REPLACE THE INFUSION TUBING, INFUSION SITE, AND INSULIN CARTRIDGE AND HE WAS ABLE TO CLEAR THE ERROR. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REPLACED AND 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 NA 034326

    Patients

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