BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY TOUCH

    MDR report key: 7774647 · Received August 10, 2018

    Report

    Report Number
    3005798905-2018-00787
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 13, 2018
    Report Date
    July 31, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST 6/8/2023.

    Description of Event or Problem · 0

    CHECKED HIS BLOOD SUGAR YESTERDAY AND HIS RESULTS WERE 359, 230 SOMETHING, THEN 220 SOMETHING. TODAY WHEN HE CHECKED THE RESULTS WERE 259, 230, 225. I ASKED WHEN THE ITEMS WERE PURCHASED? HE STATED 6 MONTHS AGO THEN CHANGED HIS ANSWER TO 2 MONTHS. I EXPLAINED IF THE STRIPS WERE OPENED 90 DAYS AGO, THEY'LL GIVE HIGH READINGS. HE THEN STATED THEY WERE OPENED 2 MONTHS AGO. HE SAID HE ONLY PURCHASED THE METER AND STRIPS. IT DIDN'T COME WITH ANYTHING ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616128 EASY TOUCH TEST STRIPS NBW MHC MEDICAL PRODUCTS, LLC. 437903

    Patients

    Seq Age Sex Outcome Treatment
    1 Male