BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1041135 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00691
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 1, 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
    VA, 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 AN ELEVATED BLOOD GLUCOSE READING OF "HI" WITH HIS TARGET RANGE BEING 70-80 MG/DL DURING THE DAY AND 150 MG/DL AT NIGHT. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS INSULIN INFUSION DEVICE AND BOLUS INSULIN OUT OF THE TUBING WHICH HE SUCCESSFULLY DID. THE PT STATED HE IS CURRENTLY ILL AND IS EXPERIENCING PAIN IN HIS NECK. ON FOLLOW UP, THE PT SAID HIS LAST READING WAS 154 MG/DL. HE STATED HE IS HAVING TESTS DONE, INCLUDING A CAT SCAN, FOR HIS HEAD AND NECK ACHES AND A COUGH THAT WILL NOT GO AWAY. HE HAS ALSO BEEN GIVEN A NEW MEDICATION AND SOME OF HIS CURRENT MEDICATION HAS BEEN INCREASED. HE SAID HE HAS HAD INCREASED ANXIETY. 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 Other| R INSULIN| INSULIN INFUSION SET