BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1731001 · Received June 17, 2010

    Report

    Report Number
    2183996-2010-01287
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    November 19, 2009
    Report Date
    May 19, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED APPROX 6 MONTHS AGO, SHE WAS HOSPITALIZED DUE TO A LOW BLOOD GLUCOSE READING. PT STATED HER MOTHER FOUND HER PASSED OUT AND SHE WAS TAKEN TO THE HOSP. PT REPORTED HER BLOOD GLUCOSE READING AT THE HOSP WAS 18 MG/DL; TREATMENT RECEIVED WAS NOT PROVIDED. PT'S NORMAL BLOOD GLUCOSE RANGE IS 140-200 MG/DL. PT STATED, SHE HAS NOT BEEN ON THE INFUSION DEVICE SINCE THIS HOSPITALIZATION APPROX 6 MONTHS AGO. PT DECLINED OFFER OF A REPLACEMENT INFUSION DEVICE. PT REPORTED, HER DOCTOR DOES NOT WANT HER TO BE ON AN INSULIN INFUSION DEVICE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN