BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9358144 · Received November 21, 2019

    Report

    Report Number
    1000113657-2019-10169
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 23, 2019
    Report Date
    December 13, 2019
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K000000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AS OF 13-DEC-2019: G4: ADDED DATE RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20: USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 1

    METER AND TEST STRIPS WERE NOT 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: THE METER MODEL AND SERIAL NUMBER OF THE ALLEGED DEFECTIVE DEVICE WAS NOT OBTAINED AT TIME OF INITIAL CALL. CALL BACK ATTEMPTS WERE MADE TO CUSTOMER IN ORDER TO OBTAIN THE INFORMATION; UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE IN ORDER TO VERIFY. THEREFORE, CATALOG # AND 510(K) COULD NOT BE ENTERED AT TIME OF REPORT TO FDA WAS FULFILLED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 163, 150, 313, 148 AND 153 MG/DL. CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. CUSTOMER WAS ALSO COMPARING RESULTS TO ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/31/2019; TEST STRIPS ARE EXPIRED AT TIME OF CALL. CUSTOMER HAD ANOTHER VIAL OF TEST STRIPS, MW335S, MANUFACTURER'S EXPIRATION DATE OF 11/30/2020, BUT CUSTOMER STATED THAT HE HAD MIXED THE STRIPS BETWEEN THE TWO VIALS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153547 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL MV2781

    Patients

    Seq Age Sex Outcome Treatment
    1