BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3913989 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04914
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    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).

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER HAS EXPERIENCED HYPERGLYCEMIA OF UP TO 30.0 MMOL/L, AND SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. THE INFUSION DEVICE HAS DISPLAYED SEVERAL E4 OCCLUSION ERRORS WHEN THERE IS 1.3-1.4 ML LEFT IN THE CARTRIDGE, AND SHE HAS BEEN ABLE TO RESOLVE THE ERRORS BY CHANGING THE CARTRIDGE, ADAPTER, AND INFUSION SET. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCTS WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389875 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR