BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4020628 · Received August 19, 2014

    Report

    Report Number
    1823260-2014-06296
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 1, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MENU BUTTON ON THE INFUSION DEVICE WAS ONLY FUNCTIONING INTERMITTENTLY. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497775 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1