BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 5608682 · Received April 26, 2016

    Report

    Report Number
    3011393376-2016-02744
    Event Type
    Injury
    Date Received
    April 26, 2016
    Date of Event
    March 22, 2016
    Report Date
    June 26, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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.

    Additional Manufacturer Narrative · 1

    DAY OF EVENT WAS CHANGED FROM THURSDAY TO TUESDAY.

    Description of Event or Problem · 1

    CALLER REPORTEDLY HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS FROM 10.2 MMOL/L - 22 MMOL/L ON MONDAY; SELF-TREATED. CALLER STATED STATED SHE WAS FOUND UNRESPONSIVE ON THURSDAY NIGHT BY HER HUSBAND AND TAKEN TO THE HOSPITAL WHERE SHE WAS ADMITTED AND TREATED WITH WITH INSULIN FOR A BLOOD GLUCOSE LEVEL OF 52 MMOL/L. CALLER REPORTED HOSPITAL SUSPECTS PUMP HAD NOT DELIVERED INSULIN. REQUESTED RETURN OF THE ALLEGED DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    CORRECTION: CALLER STATED SHE WAS FOUND UNRESPONSIVE ON TUESDAY NIGHT BY HER HUSBAND AND TAKEN TO THE HOSPITAL WHERE SHE WAS ADMITTED AND TREATED WITH WITH INSULIN FOR A BLOOD GLUCOSE LEVEL OF 52 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265278 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R