BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3874415 · Received June 16, 2014

    Report

    Report Number
    1823260-2014-04358
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    January 25, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED THE SIDE BUTTONS OF THE PUMP ARE DAMAGED. CALLER STATED HE CANNOT SET HIS INSULIN DOSE. CALLER REPORTED THE UPPER SIDE BUTTON IS COMPLETELY DAMAGED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353403 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 015 YR