BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 13342623 · Received January 25, 2022

    Report

    Report Number
    1000113657-2022-00032
    Event Type
    Injury
    Date Received
    January 25, 2022
    Date of Event
    December 28, 2021
    Report Date
    March 22, 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
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO MEDICAL INTERVENTION RELATED TO DIABETES: PARAMEDICS CONTACTED DUE TO CUSTOMER ADMINISTERING AN UNDISCLOSED AMOUNT OF INSULIN. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 22-MAR-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 PASSED 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER RESIDES IN A GROUP HOME AND THE SUPERVISOR IS CALLING ON THEIR BEHALF. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 207, 180, 375 AND 277 MG/DL. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. SUPERVISOR STATED THAT THE CUSTOMER HAD REQUIRED MEDICAL INTERVENTION ON (B)(6) 2021. SUPERVISOR STATED THAT THE CUSTOMER HAD GOTTEN A HOLD OF ONE OF HER INSULIN SYRINGES AND HAD INJECTED HERSELF WITH AN UNKNOWN AMOUNT OF INSULIN; SUPERVISOR DID NOT DISCLOSE WHICH INSULIN CUSTOMER INJECTED. SUPERVISOR ADVISED THAT PARAMEDICS HAD BEEN CALLED AS A PRECAUTION. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT OBTAINED USING THE PARAMEDICS METER HAD BEEN 314 MG/DL (FASTING/NON-FASTING UNDISCLOSED). THE PARAMEDICS HAD ADVISED THAT THE CUSTOMER'S TRUE METRIX METER WAS READING HIGHER THAN THEIR METER; SUPERVISOR WAS UNABLE TO CONFIRM IF THE TRUE METRIX METER MEMORY RESULT OF 375 MG/DL WAS THE COMPARISON RESULT. NO MEDICATION/TREATMENT WAS ADMINISTERED AND CUSTOMER WAS NOT TAKEN TO THE HOSPITAL. THE PARAMEDICS HAD ADVISED THE FACILITY TO OBSERVE THE CUSTOMER. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE FACILITY MEDICATION CART. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2023; OPEN VIAL DATE IS UNKNOWN, BUT SUPERVISOR STATED IT WAS LESS THAN FOUR MONTHS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (ONLY 4 MEMORY RESULTS PROVIDED): RESULT 1: 207 MG/DL, DATE: (B)(6) 2021, TIME: 7:47 AM, FASTING; RESULT 2: 180 MG/DL, DATE: (B)(6) 2021, TIME: 10:05 PM, FASTING; RESULT 3: 375 MG/DL, DATE: (B)(6) 2021, TIME: 4:38 PM, FASTING; RESULT 4: 277 MG/DL, DATE: (B)(6) 2021, TIME: 8:00 AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559691 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 MY4475S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other