BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1464618 · Received September 3, 2009

    Report

    Report Number
    2183996-2009-01943
    Event Type
    Injury
    Date Received
    September 3, 2009
    Date of Event
    July 28, 2009
    Report Date
    August 4, 2009
    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
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2009, THE PT'S MOTHER REPORTED THE PT WAKES UP WITH ELEVATED BLOOD GLUCOSE READINGS IN THE 250-350 MG/DL RANGE. SHE THINKS THERE IS A "POOLING" OF INSULIN AT THE PT'S INFUSION SITE. SHE STATED SHE WILL ENCOURAGE THE PT TO CALL FOR TROUBLESHOOTING. ATTEMPTS TO F/U WITH THE PT WERE UNSUCCESSFUL. 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention INSULIN INFUSION SET| INSULIN