BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX GLUCOMETER

    MDR report key: 4916027 · Received July 7, 2015

    Report

    Report Number
    MW5044145
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 7, 2015
    Manufacturer
    NOVA MAX
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT'S HUSBAND BROUGHT THE PT'S GLUCOMETER AND TEST STRIPS TO THE OUTPATIENT PHARMACY AND INFORMED THE PHARMACY TECH THAT THE METER WA GIVING ERRONEOUS READINGS. THE TECH REFERRED THE PT TO THE PHARMACIST AT THE CONSULTATION WINDOW. THE PHARMACIST CALLED THE MFR AND THE COMPANY REP ASSISTED THE PHARMACIST WITH SOME TROUBLE SHOOTING STEPS AND DETERMINED THAT THE TEST STRIPS MIGHT BE THE REASON FOR THE WRONG READINGS BUT TO BE ON THE SAFE SIDE THE COMPANY WILL SEND A NEW METER AND TEST STRIPS TO THE PT. THE REP ALSO ASKED FOR THE PT TO RETURN THE OLD METER AND HER TEST STRIPS TO THE COMPANY IN THE BOX THAT THEY PROVIDE FOR FURTHER INVESTIGATION. PT'S METER AND TEST STRIP INFO: METER SERIAL NUMBER: (B)(4), TEST STRIPS LOT NUMBER: 1020214204, TEST STRIPS EXPIRATION DATE: 07/31/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437858 NOVA MAX GLUCOMETER GLUCOMETER CGA NOVA MAX
    437859 NOVA MAX TEST STRIPS TEST STRIPS CGA NOVA MAX 1020214204

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR