BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 10047268 · Received May 12, 2020

    Report

    Report Number
    1000113657-2020-00290
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 13, 2020
    Report Date
    July 21, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 21-JUL-2020: H10: METER WAS RETURNED FOR EVALUATION. DEFECT FOUND ON REV 4. RETURNED METER - E-0 WITH CONTROLS. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. H10: MOST LIKELY UNDERLYING ROOT CAUSE: RC-079: THE CONTROL SOLUTION PEAK IS BEING DETECTED BELOW THE LOWER LIMIT OF 2.0 FOR MR2 V2.53 METER. CORRECTED SECTIONS AS OF 21-JUL-2020: H10: MOST LIKELY UNDERLYING ROOT CAUSE CORRECTED FROM "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" TO "RC-079: THE CONTROL SOLUTION PEAK IS BEING DETECTED BELOW THE LOWER LIMIT OF 2.0 FOR MR2 V2.53 METER."

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). PRODUCT WAS RETURNED FOR EVALUATION AND PENDING QC INVESTIGATION. 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 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 HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM PM FASTING RESULTS OBTAINED OF 193, 221, 169, 165 AND 174 MG/DL. THE CUSTOMER¿S EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-120 MG/DL. 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 280 MG/DL AND 264 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2021 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511779 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, TMX NFRS STARTERMG/DL MX4192S 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1