BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4180395 · Received October 17, 2014

    Report

    Report Number
    1823260-2014-08004
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    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. CUSTOMER DECLINED TO RETURN DEVICE.

    Description of Event or Problem · 1

    DOCTOR REPORTED THE CUSTOMER DOES NOT UNDERSTAND THE PUMP. DOCTOR STATED CUSTOMER WENT TO THE HOSPITAL ON (B)(6) 2014 FOR KETOSIS; WAS TREATED WITH INSULIN VIA SYRINGE. DOCTOR REPORTED THE CUSTOMER HAS THE CARTRIDGE WRONGLY INSERTED; THE PISTON ROD WAS NOT CONNECTED WITH THE CARTRIDGE. DOCTOR STATED THE PUMP WORKS CORRECTLY. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION; CUSTOMER DECLINED TO RETURN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663066 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR Hospitalization| R