BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1932888 · Received December 13, 2010

    Report

    Report Number
    2183996-2010-02610
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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

    PT WAS AT SCHOOL, AND THE INFUSION DEVICE VIBRATED. PT CHECKED THE DISPLAY AND IT APPEARED NORMAL. HE TRIED TO PRESS THE BUTTONS, BUT THE INFUSION DEVICE APPEARED "BLOCKED." HE REMOVED AND REINSERTED THE BATTERY, BUT THE INFUSION DEVICE WOULD NOT WORK OR TURN ON. PT RETURNED HOME AND BLOOD GLUCOSE WAS 250 MG/DL. NORMAL BLOOD GLUCOSE IS 120 MG/DL. HE CORRECTED HYPERGLYCEMIA BY MULTI-INJECTION THERAPY, AND HE SWITCHED TO A BACKUP INFUSION DEVICE. PT REPORTED INFUSION DEVICE DID NOT GIVE APPROPRIATE ALERT OR ERROR MESSAGE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADD'L INFO WAS PROVIDED.

    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 Required Intervention INSULIN| INSULIN INFUSION SET