BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3980953 · Received August 5, 2014

    Report

    Report Number
    1823260-2014-05876
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 27, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 INFUSION DEVICE SHUT-DOWN WITHOUT PROVIDING AN ERROR MESSAGE AND THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AS A RESULT. HE DELIVERED INSULIN VIA PEN AS TREATMENT. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457221 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1