BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 14355760 · Received May 11, 2022

    Report

    Report Number
    1000113657-2022-00276
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    March 27, 2022
    Report Date
    May 11, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. PRODUCT EVALUATION HAS BEEN COMPLETED. NO STRIP LOT NUMBER PROVIDED. UNABLE TO PERFORM RETENTION TESTING. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 22-APR-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 212, 288, 373, 414 AND 298MG/DL. THE CUSTOMER IS NOT SURE WHAT HER NORMAL GLUCOSE RANGE SHOULD BE, BUT HER GOAL IS TO BRING IT DOWN BELOW 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT AFTER EATING ICE CREAM SHE PERFORMED A BLOOD TEST AND OBTAINED A RESULT WITHIN THE 300'S MG/DL. CUSTOMER STATED THAT OVER THE COURSE OF A FEW DAYS SHE CONTINUED TO OBTAIN HIGH RESULTS. CUSTOMER STATED SHE WENT TO THE ER ON (B)(6)2022 BECAUSE HER BLOOD SUGAR WAS NOT GOING DOWN. CUSTOMER BLOOD GLUCOSE TEST RESULT IN THE ER WAS 486MG/DL. THE DIAGNOSIS WAS HYPERGLYCEMIA AND CUSTOMER WAS TREATED WITH IV INSULIN TO BRING IT DOWN. THE CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. CUSTOMER STATED THAT SHE COMBINED ALL OF HER 10 BOXES OF STRIPS IN A GLASS BOWL (UNABLE TO VERIFY STRIPS LOT #) . THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 212MG/DL DATE: (B)(6) 2022 TIME: 703AM FASTING, RESULT 2: 288MG/DL DATE: (B)(6) 2022 TIME: 702AM FASTING, RESULT 3: 373MG/DL DATE: (B)(6) 2022 TIME: 111AM NON-FASTING, RESULT 4: 414MG/DL DATE: (B)(6) 2022 TIME: 110AM NON-FASTING, RESULT 5: 298MG/DL DATE: (B)(6) 2022 TIME: 752PM (DOES NOT REMEMBER IF FASTING OR NON-FASTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037248 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, TMX NFRS STARTERMG/DL 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization