BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 14526909 · Received May 27, 2022

    Report

    Report Number
    1000113657-2022-00307
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 3, 2022
    Report Date
    July 18, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO SYMPTOMS AND METER RESULTS. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 05-MAY-2022 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. CUSTOMER DID NOT DISCLOSE IF HER DOCTOR HAD CALLED HER BACK. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 09-MAY-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 18-JUL-2022: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 48, 51, 61, 60 AND 55 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-116 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT IS LESS THAN 120 MG/DL. THE CUSTOMER REPORTED FEELING TIRED; MEDICAL ATTENTION WAS NOT REQUIRED AT THE TIME. CUSTOMER STATED THAT SHE HAD CONTACTED HER DOCTOR EARLIER THAT DAY DUE TO THE LOW RESULTS AND SYMPTOMS OF HEADACHE AND SWEATING. CUSTOMER STATED SHE WAS WAITING FOR HER DOCTOR TO CALL HER BACK. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 181 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/15/2023 AND OPEN VIAL DATE IS THREE DAYS PRIOR TO CALL. (B)(6). 1. WHAT IS THE CUSTOMER REQUESTING TRAINING ON OR ASSISTANCE WITH: LOW BLOOD. 2. WHAT INFORMATION WAS PROVIDED/ OR WHAT WAS ASSISTANCE WAS PROVIDED TO CUSTOMER: CUSTOMER STATES THAT THE METER IS GIVING LOW BLOOD RESULTS ARE NOT STABLE. CUSTOMER STATES THAT HER NORMAL GLUCOSE RANGE 110-116 FASTING AM BUT LESS THAN 120 FASTING PM. CUSTOMER STATES THAT DROPPED THE METER AND SHE IS NOT SURE IT IS WORKING PROPERLY. CUSTOMER STATES THAT SHE IS TAKING GLIPIZIDE FARXIGA, PIOGLITAZONE, TRADJENTA, SIMVASTATIN. CUSTOMER STATES THAT SHE IS GETTING THESE LOW RESULTS BUT SHE WAS NOT HAVING ANY SYMPTOMS. CUSTOMER IS CURRENTLY FEELING TIRED. CUSTOMER STATES THAT SHE CONTACTED HER DR EARLIER TODAY BECAUSE OF HER BLOOD RESULTS ON THE METER AND SHE WAS HAVING A HEADACHE AND SWEATING AND SHE IS WAITING FOR THE DR TO CALL HER BACK. 3. IS CUSTOMER SATISFIED WITH WHAT WAS PROVIDED: I WILL SEND REPLACEMENTS NO FURTHER ACTIONS IS REQUIRED. APPROVAL TO SEND OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115185 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL ZY4582S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other