BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4756188 · Received May 7, 2015

    Report

    Report Number
    3011393376-2015-00133
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Date of Event
    April 9, 2015
    Report Date
    June 17, 2015
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PUMP TRIGGERED E4; HE CHANGED THE CARTRIDGE AND THE INFUSION SET. CUSTOMER DISPOSED OF THE USED INFUSION SET AND THE CARTRIDGE. CUSTOMER STATED HIS BLOOD GLUCOSE LEVEL WAS 99-252 MG/DL; SELF-TREATED VIA THE PUMP. ON (B)(6) 2015 AT 02:30 A.M. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 319 MG/DL; HE DRANK A GLASS OF WATER AND ADMINISTERED 3.5 UNITS OF INSULIN VIA THE PUMP. CUSTOMER REPORTED HE CHECKED THE INFUSION SET AND ASSUMED THAT NO INSULIN WAS DELIVERED; DISPOSED OF THE INFUSION SET. AFTERWARDS CUSTOMER STATED HE CHANGED THE NEEDLE AND THE TUBE AGAIN. CUSTOMER REPORTED THAT AT 07:00 P.M. HIS BLOOD GLUCOSE LEVEL WAS 99 MG/DL; SELF-TREATED VIA THE PUMP. CUSTOMER STATED THAT AT 10:15 P.M. HIS BLOOD GLUCOSE LEVEL WAS 252 MG/DL; HE ADMINISTERED 2.5 UNITS OF INSULIN VIA THE PUMP. CUSTOMER REPORTED HIS BLOOD GLUCOSE LEVEL WAS THEN 160-240; SELF-TREATED. NO ADVERSE EVENT REPORTED. CUSTOMER ALLEGES THE PUMP DELIVERS TOO LOW INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300236 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR