BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1000983 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00149
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HE HAD AN ELEVATED BLOOD GLUCOSE READING OF 180 MG/DL WITH HIS NORMAL READING BEING 150MG/DL OR BELOW. HE STATED HE HAS NOT EXPERIENCED ANY SYMPTOMS AND HE CORRECTED HIS READING BY BOLUSING INSULIN. DURING TROUBLESHOOTING, THE PATIENT STATED THERE ARE AIR BUBBLES IN THE CARTRIDGE AT TIMES. HE SAID HE DOES NOT ALLOW THE INSULIN TO REACH ROOM TEMPERATURE BEFORE USING. THE PATIENT WAS ADVISED TO DO SO. THE PATIENT STATED HE PRIMES HIS INSULIN INFUSION DEVICE WHILE LAYING IT DOWN ON THE TABLE. THE PATIENT WAS ADVISED THE DEVICE SHOULD BE IN THE UPRIGHT POSITION WHILE PRIMING. HE STATED HE IS WORKING WITH HIS DOCTOR REGARDING POSSIBLE INSULIN ADJUSTMENT. HE ALSO STATED HE HAS EATEN OUT MORE DURING THE TIME HE HAS NOTICED AN INCREASE IN HIS BLOOD GLUCOSE LEVELS. HE SAID HIS DIABETES EDUCATOR HAS RECOMMENDED HE USE A SHORTER CANNULA INFUSION SET AND A COURTESY SAMPLE OF THE SHORTER SET WAS SENT TO THE PATIENT. ATTEMPTS TO FOLLOW UP WITH THE PATIENT WERE UNSUCCESSFUL. 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention INSULIN| INSULIN INFUSION SET