BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 5908566 · Received August 26, 2016

    Report

    Report Number
    1000113657-2016-01416
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Date of Event
    August 3, 2016
    Report Date
    September 6, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT IS BASED ON MEDWATCH 5063305 RECEIVED THROUGH FDA'S MEDWATCH PROGRAM REPORTED BY CUSTOMER. THE COMPLAINT IS REPORTED AS AN ADVERSE EVENT PER MW5063305. THE MANUFACTURER INSTRUCTED THE CUSTOMER PER THE PRODUCT BOOKLET GUIDE WHETHER THE E-5 ERROR IS DISPLAYED ON THE METER RETEST WITH NEW STRIP OR IT IS INDICATION OF VERY HIGH BLOOD GLUCOSE RESULTS (HIGHER THAT 600MG/DL). MANUFACTURER REP. ASSISTED CUSTOMER TO SOLVE THE CUSTOMER'S CONCERN; CUSTOMER HAD NOT ADDITIONAL TEST STRIPS VIAL TO TEST. ON THE INITIAL PHONE CALL, CUSTOMER STATED THAT IS FEELING WELL, NO MEDICAL ATTENTION REPORTED. CUSTOMER STORED THE PRODUCT IN THE KITCHEN, WHICH IS NOT RECOMMENDED BY MANUFACTURER DUE TO THE IMPROPER HUMIDITY CAN AFFECTS THE TEST STRIPS BLOOD GLUCOSE RESULTS. MANUFACTURER CONTACTED CUSTOMER WITH FOLLOW UP TO ENSURE CUSTOMER RECEIVED THE NEW PRODUCT REPLACEMENT; CUSTOMER RECEIVED. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD A POOR STORAGE (KITCHEN).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. THE COMPLAINT IS BASED ON MEDWATCH 5063305 RECEIVED THROUGH FDA'S MEDWATCH PROGRAM REPORTED BY CUSTOMER. THE COMPLAINT IS REPORTED AS AN ADVERSE EVENT PER MW5063305. THE MANUFACTURER INSTRUCTED THE CUSTOMER PER THE PRODUCT BOOKLET GUIDE WHETHER THE E-5 ERROR IS DISPLAYED ON THE METER RETEST WITH NEW STRIP OR IT IS INDICATION OF VERY HIGH BLOOD GLUCOSE RESULTS (HIGHER THAT 600MG/DL). MANUFACTURER REP. ASSISTED CUSTOMER TO SOLVE THE CUSTOMER'S CONCERN; CUSTOMER HAD NOT ADDITIONAL TEST STRIPS VIAL TO TEST. ON THE INITIAL PHONE CALL, CUSTOMER STATED THAT IS FEELING WELL, NO MEDICAL ATTENTION REPORTED. CUSTOMER STORED THE PRODUCT IN THE KITCHEN, WHICH IS NOT RECOMMENDED BY MANUFACTURER DUE TO THE IMPROPER HUMIDITY CAN AFFECTS THE TEST STRIPS BLOOD GLUCOSE RESULTS. MANUFACTURER CONTACTED CUSTOMER WITH FOLLOW UP TO ENSURE CUSTOMER RECEIVED THE NEW PRODUCT REPLACEMENT; CUSTOMER RECEIVED. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION:STRIP ISSUE AND USER'S TEST STRIP HAD A POOR STORAGE (KITCHEN).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF E-5 ERROR; TEST STRIP ERROR. E-5 ERROR OCCURRED AFTER BLOOD SAMPLE APPLIED TO TEST STRIP. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (DATE) AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2016 PRODUCED RESULT OF E-5 AFTER BLOOD SAMPLE APPLIED TO TEST STRIP. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 6/30/2017. CUSTOMER HAD NO MORE STRIP VIALS FOR TESTING. CUSTOMER WAS SATISFIED AFTER AT THE END OF THE CALL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF E-5 ERROR; TEST STRIP ERROR. E-5 ERROR OCCURRED AFTER BLOOD SAMPLE APPLIED TO TEST STRIP. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (DATE) AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2016 PRODUCED RESULT OF E-5 AFTER BLOOD SAMPLE APPLIED TO TEST STRIP. VERIFIED STORAGE OF PRODUCT IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE KITCHEN. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 6/30/2017. CUSTOMER HAD NO MORE STRIP VIALS FOR TESTING. CUSTOMER WAS SATISFIED AFTER AT THE END OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560448 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1528

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR