BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVENCARE PROVIEW SYSTEM

    MDR report key: 7048922 · Received November 21, 2017

    Report

    Report Number
    MW5073457
    Event Type
    Death
    Date Received
    November 21, 2017
    Date of Event
    November 11, 2017
    Report Date
    November 15, 2017
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NUMBER #(B)(6) BLOOD GLUCOSE OBTAINED USING EVENCARE PROVIEW GLUCOMETER X 2 RESULTS 324 AND 317; #(B)(6) BLOOD GLUCOSE OBTAINED USING A DIFFERENT GLUCOMETER RESULTS 18. CONTROL TEST COMPLETED ON (B)(6) 2017. LEVEL 2 READ (B)(6) , LEVEL 3 READ 570. EVENCARE PROVIEW GLUCOSE MONITOR GTIN (B)(4), SN: (B)(4), REF MPH 4540, RF16EMQ. EVENCARE PROVIEW TEST STRIPS GTIN (B)(4), EXP (17): 04/19/2019, LOT (10): ARD20Z1A1. EVENCARE PROVIEW GLUCOSE CONTROL SOLUTIONS: GTIN(B)(4), EXP(17): 02/03/2019, LOT (10): 6B02A047603B04, REF MPH4560.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829416 EVENCARE PROVIEW SYSTEM GLUCOMETER AND TEST STRIPS NBW MEDLINE INDUSTRIES ARD20Z1A1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| H