BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7361854 · Received March 22, 2018

    Report

    Report Number
    1000113657-2018-00342
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 26, 2018
    Report Date
    April 5, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT # (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER ON (DATE) IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN AND THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION SINCE THE LAST CALL.

    Description of Event or Problem · 0

    CONSUMER COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. COMPLAINT WAS INITIALLY REPORTED ON (B)(6) 2018. DURING ATTEMPT TO TROUBLESHOOT, CUSTOMER DISCONNECTED THE CALL. CUSTOMER WAS CALLED BACK, STATED SHE DID NOT WANT TO PROCEED AND DISCONNECTED THE CALL AGAIN. ON (B)(6) 2018, CUSTOMER CALLED AND AGAIN STATED THE METER WAS READING HIGH. CUSTOMER STATED SHE WAS DRIVING AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. CUSTOMER WAS GOING TO CALL BACK WHEN SHE RETURNED HOME. CONTACT WAS MADE WITH THE CUSTOMER THAT SAME DAY AND DURING THAT CALL, THE CUSTOMER STATED SHE WAS HAVING SYMPTOMS OF BLURRED VISION AND INCREASED THIRST; CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 120 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. CUSTOMER REFUSED TO ANSWER FURTHER QUESTIONS AND DISCONNECTED THE CALL. CUSTOMER WAS CALLED BACK AND VOICEMAIL WAS LEFT. CONTACT WAS MADE AGAIN WITH THE CUSTOMER ON (B)(6) 2018. CUSTOMER STILL REPORTED THE SAME SYMPTOMS BUT DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 162, 145, 198 AND 179 MG/DL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER ON (DATE) IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN AND THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. COMPLAINT WAS INITIALLY REPORTED ON (B)(6) 2018. DURING ATTEMPT TO TROUBLESHOOT, CUSTOMER DISCONNECTED THE CALL. CUSTOMER WAS CALLED BACK, STATED SHE DID NOT WANT TO PROCEED AND DISCONNECTED THE CALL AGAIN. ON (B)(6) 2018, CUSTOMER CALLED AND AGAIN STATED THE METER WAS READING HIGH. CUSTOMER STATED SHE WAS DRIVING AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. CUSTOMER WAS GOING TO CALL BACK WHEN SHE RETURNED HOME. CONTACT WAS MADE WITH THE CUSTOMER THAT SAME DAY AND DURING THAT CALL, THE CUSTOMER STATED SHE WAS HAVING SYMPTOMS OF BLURRED VISION AND INCREASED THIRST; CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98 - 120 MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. CUSTOMER REFUSED TO ANSWER FURTHER QUESTIONS AND DISCONNECTED THE CALL. CUSTOMER WAS CALLED BACK AND VOICEMAIL WAS LEFT. CONTACT WAS MADE AGAIN WITH THE CUSTOMER ON 02/27/2018. CUSTOMER STILL REPORTED THE SAME SYMPTOMS BUT DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 162, 145, 198 AND 179 MG/DL. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206090 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2649

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY| SECOND THERAPY