BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFYNOW

    MDR report key: 8206295 · Received December 28, 2018

    Report

    Report Number
    MW5082683
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    December 24, 2018
    Report Date
    December 27, 2018
    Manufacturer
    WERFEN COMPANY/ACCRIVA DIAGNOSTIC, INC.
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TH INSTRUMENT IS THE VERIFYNOW MANUFACTURED BY INSTRUMENTATION LABORATORY/A WERFEN COMPANY. THE DEVICE IS USED FOR DETERMINING A PATIENT'S RESPONSE TO PLAVIX AND ASPIRIN. OVER THE PAST YEAR WE HAVE REPORTED NUMEROUS TESTING/INSTRUMENT FAILURES TO IL. WE WERE NOTIFIED TODAY THAT THERE IS A RANDOM ISSUE WITH TEST CARTRIDGES WHERE A ¿FAULTY¿ FILTER CAN ALLOW BLOOD TO SEEP FROM THE CARTRIDGE INTO THE ANALYZER. THEY STATED THERE IS NO IMPACT TO PATIENT RESULTS, BUT WE ARE CONVINCED THAT THIS IS ACCURATE. THEY HAVE OFFERED TO PROVIDE US WITH ADDITIONAL BACK UP INSTRUMENTS AT NO COST UNTIL THEY ARE ABLE TO FIND RESOLUTION, BUT TO DATE ARE NOT SENDING OUT ANY PRODUCT RECALL OR PRODUCT ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044032 VERIFYNOW SYSTEM, AUTOMATED PLATELET AGGREGATION JOZ WERFEN COMPANY/ACCRIVA DIAGNOSTIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R