BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1454854 · Received August 21, 2009

    Report

    Report Number
    2183996-2009-01788
    Event Type
    Injury
    Date Received
    August 21, 2009
    Date of Event
    July 10, 2009
    Report Date
    July 24, 2009
    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 2009, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE HAS BEEN ELEVATED TO 250-423 MG/DL FOR THE PAST 2 WEEKS. SHE STATED THAT HER BLOOD GLUCOSE MEASURED 423 MG/DL THIS MORNING AND SHE BOLUSED 8 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. AT THE TIME OF THE REPORT HER BLOOD GLUCOSE MEASURED 362 MG/DL. SHE STATED THAT SHE CHANGED HER INSULIN CARTRIDGE, INFUSION SITE AND SHE BOLUSED 2 UNITS OF INSULIN AND INSULIN DID DRIP FROM THE END OF THE INFUSION TUBING. SHE REPORTED THAT WHEN THE INFUSION DEVICE DELIVERS INSULIN THE PISTON ROD MAKES A "WEIRD NOISE." SHE STATED THAT NO INSULIN HAS BEEN SPILLED IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. THE PATIENT 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 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 44 YR Required Intervention INSULIN INFUSION SET| INSULIN