BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1559312 · Received December 11, 2009

    Report

    Report Number
    2183996-2009-02936
    Event Type
    Injury
    Date Received
    December 11, 2009
    Date of Event
    November 29, 2009
    Report Date
    December 2, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE INFUSION DEVICE DOES NOT CORRECTLY DELIVER INSULIN. IN 2009, SHE FELT VERY SICK AND HIS BLOOD GLUCOSE RANGED FROM 180-350 MG/DL DESPITE BOLUSING THROUGH THE INFUSION DEVICE AND INJECTING INSULIN VIA SYRINGE. THE NEXT DAY, SHE ALSO EXPERIENCED ELEVATED BLOOD GLUCOSE (VALUES NOT PROVIDED) DESPITE BOLUSING THROUGH THE INFUSION DEVICE AND INJECTION INSULIN VIA SYRINGE. SHE STATED THAT SHE VOMITED AND FELT VERY SICK AND SHE WAS ADMITTED TO THE HOSPITAL. HER NORMAL BLOOD GLUCOSE LEVEL IS 150 MG/DL. NO FURTHER INFO IS AVAILABLE.

    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 49 YR Hospitalization| R INSULIN| INSULIN INFUSION SET