BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 1261291 · Received December 8, 2008

    Report

    Report Number
    2183996-2008-01840
    Event Type
    Injury
    Date Received
    December 8, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 14, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 143-391 MG/DL SINCE THE PREVIOUS DAY. HER TARGET BLOOD GLUCOSE LEVEL IS 130 MG/DL. SHE CHANGED HER INSULIN CARTRIDGE, INFUSION SITE, AND INFUSION TUBING THIS MORNING AND SHE SWITCHED FROM HUMALOG TO NOVOLOG. SHE STATED THAT SIX DAYS PRIOR, HER BLOOD GLUCOSE ELEVATED TO 435 MG/DL BECAUSE SHE DROPPED HER INFUSION DEVICE AND SHE WAS RECEIVING AIR INSTEAD OF INSULIN. THE PATIENT CALLED FOR ASSISTANCE AT THAT TIME WITH CHANGING THE INSULIN CARTRIDGE BUT DID NOT REPORT BLOOD GLUCOSE ISSUES. TWO WEEKS AGO THE PATIENT WAS INSTRUCTED PER HER PHYSICIAN TO INCREASE HER BASAL RATES FROM 12:00AM-7:00AM FROM 1.1 UNITS PER HOUR TO 1.2 UNITS PER HOUR. SHE WAS ASSISTED WITH MAKING THE ADJUSTMENT. FURTHER ATTEMPTS TO REACH THE PATIENT FOR FOLLOW UP WERE UNSUCCESSFUL. THE PATIENT 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-CHECK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR INSULIN| INSULIN INFUSION SET