BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2770292 · Received September 28, 2012

    Report

    Report Number
    2183996-2012-01449
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NURSE REPORTED THE INFUSION DEVICE DOES NOT CORRECTLY DELIVER INSULIN WHEN THERE ARE 90 IU OF INSULIN LEFT IN THE CARTRIDGE. THIS HAS OCCURRED 3 TIMES, AND PT WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS THE FIRST TIME. IT IS UNK WHAT TREATMENT THE PT RECEIVED WHEN HE WAS HOSPITALIZED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP AND