BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4812396 · Received June 2, 2015

    Report

    Report Number
    3011393376-2015-00785
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 7, 2015
    Report Date
    January 6, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    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 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. DEVICE WAS RETURNED BY CUSTOMER TO ROCHE AFFILIATE. DEVICE WAS LOST IN TRANSPORT BETWEEN AFFILIATE AND INVESTIGATION UNIT AND WAS UNABLE TO BE LOCATED SO NO INVESTIGATION COULD BE PERFORMED. DEVICE LOST IN TRANSIT.

    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. DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    FLIU REPORTED A DEFECTIVE DISPLAY ON THE PUMP. NO ADVERSE EVENT REPORTED. ALLEGED PUMP HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355689 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR