BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7269941 · Received February 14, 2018

    Report

    Report Number
    1000113657-2018-00181
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    January 22, 2018
    Report Date
    February 14, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00052569138557
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE : (B)(4) USER HAD AN INACCURATE REFERENCE: COMPETITOR'S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR'S BGM SYSTEM TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2018 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; 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 REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 312, 240, 261, 182 AND 175 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 130 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT TWO MONTHS PRIOR TO CALL SHE TOOK THE METER TO HER DOCTOR BECAUSE OF HIGH AND ERRATIC BLOOD GLUCOSE RESULTS OBTAINED. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER TO METER COMPARISON OF 202 MG/DL USING TRUEMETRIX METER AND 171 MG/DL USING DOCTOR'S DEVICE. CUSTOMER DID NOT PROVIDE ERRATIC BLOOD GLUCOSE RESULTS THAT WERE OF CONCERN. NO TREATMENT WAS GIVEN AT DOCTOR'S OFFICE AND NO NEW MEDICATIONS WERE PRESCRIBED. DURING THE CALL ON (B)(6) 2018, 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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/23/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :312MG/DL DATE: (B)(6) 2018 TIME:6:53AM FASTING. RESULT 2 :240MG/DL DATE: (B)(6) 2018 TIME:6:43AM FASTING. RESULT 3 :261MG/DL DATE: (B)(6) 2017 TIME:3:47AM FASTING. RESULT 4 :182MG/DL DATE: (B)(6) 2017 TIME:5:15AM FASTING. RESULT 5 :175MG/DL DATE: (B)(6) 2017 TIME:4:56AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115531 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2600 00052569138557

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR