BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4200540 · Received October 24, 2014

    Report

    Report Number
    1823260-2014-08263
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 16, 2014
    Report Date
    February 20, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). 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

    REPORTER STATED THE CUSTOMER EXPERIENCED HYPERGLYCEMIA OF 17.4 MMOL/L, AND HE WAS UNABLE TO LOWER HIS BLOOD GLUCOSE BY CHANGING THE INFUSION SET AND DELIVERING INSULIN VIA THE INFUSION DEVICE. HE TREATED HYPERGLYCEMIA BY DELIVERING A 5.0 UNIT INSULIN INJECTION. HE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679082 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1