BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 5154171 · Received October 15, 2015

    Report

    Report Number
    3011393376-2015-04282
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    July 21, 2015
    Report Date
    December 9, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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

    CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 40 MMOL/L AND KETOACIDOSIS. HE STARTED USING THE INSULIN PEN, AND MANAGED TO GET THE BLOOD GLUCOSE LEVEL DOWN TO 24 MMOL/L. HE CONTACTED HOSPITAL, AND WAS HOSPITALIZED. WHEN BLOOD GLUCOSE LEVEL WAS MEASURED AT THE HOSPITAL IT WAS 19.0 MMOL/L. HE WAS HOSPITALIZED TWO DAYS. CUSTOMER THINKS THE PUMP DELIVERS TOO LITTLE INSULIN. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684407 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR Hospitalization