BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1213507 · Received October 27, 2008

    Report

    Report Number
    2183996-2008-01628
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 15, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HAVING TO SWITCH TO HER BACKUP INFUSION DEVICE DUE TO ELEVATED BLOOD GLUCOSE OF 300 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 120-140 MG/DL. SHE STATED THAT IF HER BLOOD GLUCOSE WAS ELEVATED 300 MG/DL, SHE WOULD BOLUS 11 UNITS OF INSULIN. HER READINGS DID NOT DECREASE UNTIL SHE SWITCHED TO THE BACKUP DEVICE. SHE STATED THAT SHE CHANGED THE INSULIN CARTRIDGE OF THE PRIMARY INFUSION DEVICE AND NOTICED CONDENSATION IN THE CARTRIDGE COMPARTMENT. SHE STATED THAT SHE DOES NOT RECALL SPILLING INSULIN IN THE CARTRIDGE COMPARTMENT AND THE INSULIN CARTRIDGE DID NOT APPEAR TO BE CRACKED. 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