BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1192448 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01540
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 28, 2008
    Report Date
    September 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HIS BLOOD GLUCOSE WAS ELEVATED TO 400 MG/DL. THE PREVIOUS DAY, HE REPORTED THAT THE DOWN BUTTON OF HIS INFUSION DEVICE WAS NOT FUNCTIONING (REPORTED SEPARATELY) AND HE WAS EDUCATED ON HOW TO PERFORM A STANDARD BOLUS. HE STATED THAT HE DID NOT REMEMBER IF HE WAS TOLD TO PRESS THE CHECK BUTTON TO CONFIRM THE BOLUS. HE ATTEMPTED TO BOLUS THE EVENING OF THE DAY OF EVENT, AND AGAIN IN THE NEXT DAY, AND THE BOLUSES WERE NOT DELIVERED. HE WAS EDUCATED ON PERFORMING A STANDARD BOLUS. HE WAS ABLE TO SUCCESSFULLY BOLUS AT THE TIME OF THE REPORT. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

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