BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 6495686 · Received April 14, 2017

    Report

    Report Number
    3011393376-2017-02177
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    March 29, 2017
    Report Date
    July 25, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    CALLER ALLEGED THAT THE DEVICE PROVIDED AN INACCURATE OR UNINTENDED OVER OR UNDER DELIVERY OF BOLUS OR BASAL INSULIN. DURING THE LAST 4 WEEKS IN THE MORNING REPEATEDLY BLOOD GLUCOSE VALUES OF 11.2 MMOL/L TO 15 MMOL/L. NO ADVERSE EVENT ALLEGED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276006 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR