BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 12024050 · Received June 18, 2021

    Report

    Report Number
    1000113657-2021-00391
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 18, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-018: USER HAS HIGH GLUCOSE VALUE. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 27-MAY-2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HER CONDITION HAD IMPROVED AND SHE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 01-JUN-2021 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 · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 264, 259, 240, 239 AND 234 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-140 MG/DL AND EXPECTED PM NON-FASTING BLOOD GLUCOSE TEST RESULT IS 150 MG/DL. THE CUSTOMER REPORTED FEELING DIZZY AT THE TIME OF THE CALL; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER STATED THAT IN (B)(6) (COULD NOT RECALL EXACT DATE) SHE HAD OBTAINED A BLOOD GLUCOSE TEST RESULT OF 500 MG/DL NON-FASTING USING THE TRUE METRIX METER AND HAD CALLED THE AMBULANCE. CUSTOMER STATED THAT DUE TO THE HIGH BLOOD GLUCOSE TEST RESULT SHE HAD ADMINISTERED THREE INSULIN SHOTS. CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN TAKEN BY THE EMT'S WAS 190 MG/DL NON-FASTING. CUSTOMER WAS TAKEN TO THE HOSPITAL SO HER BLOOD GLUCOSE LEVEL COULD BE MONITORED. CUSTOMER WAS NOT TREATED WITH ANY MEDICATION, WAS DISCHARGED THE SAME DAY AND ADVISED TO FOLLOW-UP WITH HER DOCTOR. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 234 MG/DL USING TRUE METRIX METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/30/2022 AND TEST STRIPS HAVE BEEN OPEN FOR ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; CUSTOMER STATED ALL TESTS WERE AM NON-FASTING TAKEN (B)(6) 2021): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919652 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX CVS 100CT12/CASE MG/DL ZX4226S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization