BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 5684168 · Received May 26, 2016

    Report

    Report Number
    3011393376-2016-03539
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    April 29, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 ORSIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    CALLER REPORTEDLY EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS FROM 241-335; TOOK CORRECTION VIA PUMP WITHOUT SUCCESS. CALLER WAS REFERRED TO THE ER; TREATMENT RECEIVED WAS NOT PROVIDED. CALLER REPORTED A BLOOD GLUCOSE READING OF 121 MG/DL AFTER THE ER VISIT. REQUESTED RETURN OF THE ALLEGED DEVICE FOR EVALUATION AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337612 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization