BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 17546227 · Received August 14, 2023

    Report

    Report Number
    1000113657-2023-00421
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 20, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 20-SEP-2023: ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). E4: INITIAL REPORTER ALSO SENT REPORT TO FDA. G2: REPORT SOURCE. H10: CONSUMER COMPLAINT WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM (MW5120601). I WAS IN THE HOSPITAL WITH PNEUMONIA FOR A WEEK AND MY BLOOD GLUCOSE LEVEL WENT DANGEROUSLY HIGH. I WAS PUT ON INSULIN IN AND OUT OF THE HOSPITAL. I HAD PURCHASED TWO WALGREENS TRUE METRIX MONITORS (ONE FOR MY ADOPTIVE FAMILY AS WELL). I HAD TO SEE MY GP (GENERAL PRACTIONER) AS PART OF MY RELEASE ABOUT MY BLOOD SUGAR LEVELS. I NOTICED THAT MY READINGS WERE DIFFERENT FROM THE HOSPITALS. ON (B)(6) 2023, AT THE DR'S OFFICE, I WAS GIVEN THE IN-OFFICE TEST. I CHECKED WITH THE MA, SHE SAID THAT THEY HAVE TO HAVE THEIR DEVICES CERTIFIED AND SHE TOLD ME THAT THEY RECORD THE LOT NUMBERS AND DATE CODES OF THE TEST STRIPS ON THE PATIENT'S FILE. MY READING WAS 148. TEST STRIPS LOT: 2B5235S, EXP 2024-10-31. WITHIN NINE MINUTES, I WAS IN MY CAR, TESTING BOTH UNITS. BOTH UNITS READ 178 EXACTLY. THAT IS 30 POINTS DIFFERENT FROM THE TRUE READING FROM THE HOSPITAL. I WAS TOLD IF MY READING WAS ABOVE 300 OR BELOW 70, I NEEDED TO GO TO THE HOSPITAL. FOR EXAMPLE, IF BOTH OF THESE TWO MONITORS READ 90, THAT WOULD BE A GREAT READING. HOWEVER, SINCE THEY ARE 30 POINTS OFF, MY READING IS ACTUALLY 60. THAT WOULD MEAN THAT I SHOULD GO TO THE HOSPITAL. IF I NEVER TOOK BOTH OF THESE METERS, I WOULD NOT HAVE KNOWN AND COULD HAVE HAD LIFE THREATENING RESULTS AND NOT KNOWN IT. ON (B)(6) 2023, I CALLED TRUE METRIX MANUFACTURER, TRIVDIA HEALTH, PH. 1-800-803-6025. I SPOKE TO A YOUNG LADY IN CUSTOMER SERVICE AND EXPLAINED MY PROBLEM. I DO NOT BLAME HER FOR HER RESPONSE, AS I COULD TELL THAT SHE WAS READING IT. SHE SAID THAT SINCE THE HOSPITAL DEVICE WAS DIFFERENT THAN USING A TRUE METRIX DEVICE, THERE WOULD BE A DIFFERENCE. I ADVISED HER THAT 30 POINTS WAS NOT ACCEPTABLE. I ASKED FOR HER SUPERVISOR TO CALL ME. (B)(4), A TEAM LEADER, CALLED ME. I EXPLAINED THAT THIS WAS A LIFE-THREATENING SITUATION. IT APPEARED TO ME THAT SHE DID NOT SEEM TO THINK THAT THIS WAS A BIG DEAL. PERHAPS I AM WRONG. SHE SAID THAT SHE WOULD GLADLY REPLACE BOTH UNITS. I SAID THAT I WANTED NO PART OF THESE PRODUCTS AS I THINK THAT THEY COULD CAUSE SOMEONE'S DEMISE. AS I TOLD HER, THEY ARE LOSING TWO CUSTOMERS BUT WE ARE SAVING OUR LIVES. SHE GAVE ME A CASE NUMBER OF (B)(4). I HAVE BOTH MONITORS AND THE TEST STRIPS THAT YOU CAN HAVE FOR YOUR TESTING PURPOSES. IF I AM CORRECT, I THINK THAT PEOPLE NEED TO BE WARNED OF DANGER WITH THESE MONITORS. MY NAME IS (B)(6). DR'S BLOOD GLUCOSE MONITOR WAS 148, RECENTLY CERTIFIED AS ACCURATE. THE TWO TRUE METRIX RESULTS WITHIN NINE MINUTES WAS 178. REFERENCE REPORT: MW5120600.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055: 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO REPORTED COMPLAINT TO RETAILER (WALGREENS) AND EXPRESSED RISK FACTOR OF METER USE. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM AM FASTING METER TO METER COMPARISON PERFORMED DURING FOLLOW-UP DOCTOR'S APPOINTMENT ON DAY OF CALL. CUSTOMER STATED THAT THE DOCTOR TESTED HIS BLOOD SUGAR WITH HIS METER AND RESULT WAS 148 MG/DL FASTING AM AND "5 MINUTES LATER" HE TESTED WITH THE METRIX AIR METER WHICH IS HIS RELATIVE'S METER AND HIS TRUE METRIX METER AND HE GOT A RESULT OF 178 MG/DL WITH ONE OF THE METERS AND 177 MG/DL WITH THE OTHER METER. CUSTOMER DIDN'T WANT TO SPECIFY WHICH METER - TRUE METRIX OR TRUE METRIX AIR - DISPLAYED 178 MG/DL AND 177 MG/DL (ADDITIONAL REPORT REFERENCE (B)(4)). THE CUSTOMER DOES NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE AND HE ASSUMES THAT 148 MG/DL AM FASTING RESULT WITH THE DOCTOR' DEVICE IS HIS GLUCOSE RANGE. 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 TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2024; OPEN VIAL AND STORAGE WERE NOT DISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50227 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX GNP 30CT24/CASE MG/DL ZB5235S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown