BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY TOUCH

    MDR report key: 7471113 · Received April 27, 2018

    Report

    Report Number
    3005798905-2018-00480
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    March 28, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MHC MEDICAL PRODUCTS, LLC
    Product Code
    NBW
    PMA / PMN Number
    K073492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONTINUES TO RECEIVE HIGH READINGS. METER READING WAS 133 AND HIS READING IS USUALLY AROUND 100. HE USED THE H/LO SOLUTION BUT HIS READINGS ARE STILL HIGHER THAN USUAL. HE WAS WONDERING IF HE WAS DOING SOMETHING WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312627 EASY TOUCH GLUCOSE METER NBW MHC MEDICAL PRODUCTS, LLC NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1