BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1081221 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01083
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 6, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 08, THE PT REPORTED THAT LAST WEEK HE HAD ELEVATED BLOOD GLUCOSE READINGS UP TO OVER 500 MG/DL AT BEDTIME. HE STATED HE WOKE UP IN THE MIDDLE OF THE NIGHT WITH DRY HEAVES. HE STATED HIS BLOOD GLUCOSE READINGS HAVE RETURNED TO NORMAL AFTER RECEIVING ADD'L TRAINING ON HIS INSULIN INFUSION DEVICE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    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