BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE PRISM

    MDR report key: 11045729 · Received December 18, 2020

    Report

    Report Number
    MW5098452
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    December 12, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ARKRAY FACTORY USA, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    GLUCOMETER FAILED TO CORRECTLY IDENTIFY HYPOGLYCEMIA IN A DIABETIC PATIENT. THE MACHINE READ A NORMAL READING X'S 2. HOSPITAL LAB VALUES SHOW A SEVERELY HYPOGLYCEMIC READING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499091 ASSURE PRISM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW ARKRAY FACTORY USA, INC. 00015482530013

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening