BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1180098 · Received September 29, 2008

    Report

    Report Number
    2183996-2008-01451
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 7, 2008
    Report Date
    September 9, 2008
    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
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008 THE PATIENT REPORTED THAT HE IS NOT ABLE TO RETRACT THE PISTON ROD OF HIS INFUSION DEVICE. HE STATED THAT THE PISTON ROD APPEARS TO BE STUCK AT THE HALFWAY POINT AND THE INFUSION DEVICE IS MAKING A LOUD "HUMMING" SOUND. HE STATED THAT HE INSERTED A NEW BATTERY INTO THE INFUSION DEVICE AND ATTEMPTED TO RETRACT THE PISTON ROD AND E10 (CARTRIDGE) ERROR WAS DISPLAYED. HE ALSO REPORTED EXPERIENCING E6 (MECHANICAL) ERRORS OVER THE PAST "COUPLE" OF DAYS. HE STATED THAT "THE INSIDE OF THE PUMP IS DUSTY LOOKING." HE STATED THAT THE INFUSION DEVICE HAD NOT BEEN EXPOSED TO MOISTURE. HE FEELS THE ERRORS HAVE CAUSED HIS BLOOD GLUCOSE TO ELEVATE. HE EXPERIENCED A BLOOD GLUCOSE READING OF "HI" (OVER 500 MG/DL) ON HIS BLOOD GLUCOSE MONITOR AND HE BOLUSED THROUGH HIS INFUSION DEVICE. HE STATED THAT HE BOLUSED 40 UNITS OF INSULIN IN A 6 HOUR PERIOD OF TIME AND HIS BLOOD GLUCOSE RETURNED TO A NORMAL LEVEL OF 150 MG/DL. HE STATED THAT HIS NORMAL BLOOD GLUCOSE LEVEL IS NOT OVER 200 MG/DL. HE WAS ADVISED TO SWITCH TO HIS BACKUP 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 Other| R INSULIN| INSULIN INFUSION SET