BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1031271 · Received April 18, 2008

    Report

    Report Number
    2183996-2008-00561
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT'S HUSBAND AND THE PT CALLED FOR ASSISTANCE IN CHANGING THE PT'S BASAL RATES ON HER INSULIN INFUSION DEVICE AS HER DR TOLD HER TO INCREASE HER BASAL RATES BY 0.2 UNITS OF INSULIN PER HR FOR EACH HR OF THE DAY. THE PT SAID SHE HAD AN ELEVATED BLOOD GLUCOSE READING OF 550 MG/DL WITH HER NORMAL RANGE BEING 80-140 MG/DL. SHE STATED SHE CORRECTED HER READING BY BOLUSING 6 UNITS OF INSULIN. A COMPANY REPRESENTATIVE ASSISTED THE PT IN CHANGING HER BASAL RATES. ON FOLLOW UP, THE PT STATED HER BLOOD GLUCOSE READINGS HAVE RETURNED TO HER NORMAL RANGE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 Other| R INSULIN| INSULIN INFUSION SET