BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1933139 · Received December 13, 2010

    Report

    Report Number
    2183996-2010-02617
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    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

    PT EXPERIENCED HYPERGLYCEMIA OF 300 MG/DL FOR 24 HOURS. THERE WAS NO INSULIN AT THE END OF THE INFUSION SET LUER CONNECTION, AND IT WAS REPORTED THE INFUSION DEVICE DID NOT DELIVER INSULIN. NO ALARMS WERE RECEIVED TO INDICATE OCCLUSION OR MALFUNCTION. HOMECARE NURSE TESTED INFUSION DEVICE BY DELIVERING A BOLUS, AND NO INSULIN WAS DELIVERED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. INFUSION SET HAD BEEN DISCARDED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN