BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4972928 · Received August 3, 2015

    Report

    Report Number
    3004193489-2015-00108
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    July 13, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT IS CONFIRMED. ALTHOUGH THE ROOT CAUSE COULD NOT BE CONCLUSIVELY IDENTIFIED, A POTENTIAL CONTRIBUTORY ROOT CAUSE MAY BE RELATED TO EXPOSURE OF THE TEST STRIPS TO EXTREMES IN TEMPERATURES CONTRARY TO THE STORAGE AND HANDLING ASA INDICATED IN LABEL COPY (IFU/PACKAGE INSERT). THIS IS FURTHER SUPPORTED BY THE RESULTS OF RETAIN TEST STRIP TESTING WHICH INDICATES THE RETAIN STRIPS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL. TEST STRIP LOT # 1020213252, EXPIRATION DATE: 03/2015 ,CONTROL SOLUTION LOT NONE. PER LABEL COPY/ PACKAGE INSERT. UNEXPECTED RESULTS. HIGH OR LOW BLOOD GLUCOSE RESULTS CAN INDICATE POTENTIALLY SERIOUS MEDICAL CONDITIONS. IN CASE OF AN UNEXPECTED RESULT, YOU SHOULD REPEAT THE TEST USING A NEW TEST STRIP. IF THE RESULT IS STILL UNEXPECTED, OR THE READING IS NOT CONSISTENT WITH HOW YOU FEEL, CONTACT YOUR HCP AND TREAT AS PRESCRIBED. NOVA MAX TEST STRIP INSERT- QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIME YOU OPEN A NEW VIAL OF TEST STRIPS. NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. THE DHR WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CONSUMER CALLED INTO CUSTOMER CARE CONCERNED ABOUT HIS BLOOD GLUCOSE READINGS. THE CONSUMER WAS DECLINED TO PROVIDE ANY FURTHER INFO REGARDING THE REPORTED EVENT. CONSUMER REFUSED TO RETRIEVE ANY BG READINGS FROM HIS METER. CONSUMER STATED "ALL" OF HIS READING WERE INCORRECT. CONSUMER STATED HE TOOK AN ADDITIONAL 2 UNITS OF INSULIN BASED ON "ONE" OF HIS INACCURATE RESULT THAT HE WOULD NOT DISCLOSE. NO CS TEST WAS PERFORMED ON TS IN QUESTION PRIOR TO CALLING. CONSUMER WOULD NOT DISCLOSED IF THE BG TESTS WERE PERFORMED ACCORDING TO (B)(4) OWNERS GUIDE, CONSUMER WOULD NOT DISCLOSE IF THERE HAS BEEN ANY RECENT CHANGES IN DIET, OR MEDICATION, LATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505270 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020213252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK