BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1002998 · Received February 20, 2008

    Report

    Report Number
    2183996-2008-00177
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 3, 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
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED THAT SHE BEGAN USING HER NEW INSULIN INFUSION DEVICE, AND HER BLOOD GLUCOSE READINGS IMMEDIATELY WENT TO OVER 600 MG/DL. SHE STATED SHE WOULD BOLUS TO CORRECT HER READINGS, BUT THE READINGS WOULD THEN ELEVATE AGAIN. THE PT STATED, SHE PROGRAMMED HER BASAL RATES AGAIN TODAY, AND BELIEVES SHE NEVER HAD HER BASAL RATES PROGRAMMED IN CORRECTLY BEFORE. THE PROPER PROCEDURE TO SET BASAL RATES AND CHANGE THE INSULIN CARTRIDGE WERE REVIEWED WITH THE PT. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 YR Other| R INSULIN INFUSION SET| INSULIN