BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3841417 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03890
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    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).

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT THERE WAS A VERTICAL LINE GOING ACROSS THE DISPLAY OF THE PATIENT'S BLOOD GLUCOSE MONITOR THAT AFFECTED THE VALUES DISPLAYED ON THE DEVICE. NO ADVERSE EVENT WAS REPORTED. THE BLOOD GLUCOSE MONITOR WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318230 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1