BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002769706-2015-00155

    MDR report key: 5254154 · Received November 30, 2015

    Report

    Report Number
    3002769706-2015-00155
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Report Date
    November 10, 2015
    PMA / PMN Number
    K891385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ON (B)(6) 2015 TO REPORT A FALSE NEGATIVE RESULT WHEN USING VIDAS ® PC COMPUTER HP RP5700. THE TEST IN QUESTION WAS LYME TOTAL (LYT), RESULTS WERE 0.00 AND THE RFV WAS 0 OR -1. CUSTOMER REPORTED RESULTS WERE PROVIDED TO THE PHYSICIAN, NO DELAY.

    Patients

    Seq Age Sex Outcome Treatment
    1