BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1C NOW SELF CHECK

    MDR report key: 6106101 · Received November 12, 2016

    Report

    Report Number
    MW5066077
    Event Type
    Malfunction
    Date Received
    November 12, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 12, 2016
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Product Code
    LCP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED INTERNAL QC TEST. CUSTOMER SERVICE NOT AVAILABLE. IT IS ALSO POORLY DESIGNED WITH A 50/50 CHANCE OF MAKING A WRONG CHOICE WHICH WILL CAUSE THE A1C TEST TO NOT TO BE ABLE TO BE PERFORMED. DIABETIC FAILED A1C TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749385 A1C NOW SELF CHECK A1C NOW SELF CHECK LCP POLYMER TECHNOLOGY SYSTEMS, INC. 1531548

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other AMLODIPINE| ATENOLOL| BENICAR | BUDESONIDE| CALCIUM| CETIRIZINE| CLONIDINE| D3| ELIQUIS| FENTANYL TRANSDERMAL| INSULIN ASPART| INSULIN GLARGINE| MONTELUKAST| PREDNISONE| RANITIDINE| RESTORIL| ROXICODONE | SIMVASTATIN| TERAZOSIN| TESTOTERONE| WELCHOL