BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11668490 · Received April 14, 2021

    Report

    Report Number
    1000113657-2021-00259
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 18, 2021
    Report Date
    July 9, 2021
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION AS OF (B)(6) 2021: CORRECTION ON SECTION B1 TO REMOVE PRODUCT PROBLEM SELECTION SINCE PRODUCT WAS RETURNED AND EVALUATED. INVESTIGATION YIELD NO DEFECT FOUND, THEREFORE THE PRODUCT PROBLEM CATEGORY DOES NOT APPLY.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED. NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020 USER'S TEST STRIP HAD POOR STORAGE. NOTE 1: MANUFACTURER CONTACTED CUSTOMER ON A FOLLOW-UP CALL ON 19-MAR-2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HE CURRENTLY STILL WAS EXPERIENCING SYMPTOMS. CUSTOMER HAD BEEN HOSPITALIZED (B)(6) 2021. CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL WAS 296 MG/DL; THE DIAGNOSIS WAS HYPERGLYCEMIA AND MEDICATION HAD BEEN ADMINISTERED TO LOWER HIS BLOOD GLUCOSE. CUSTOMER HAD BEEN DISCHARGED THE SAME DAY AND INSULIN HAD BEEN INCREASED FROM 10 TO 20 UNITS. CUSTOMER HAD TESTED USING THE TRUE METRIX METER AND OBTAINED A BLOOD GLUCOSE TEST RESULT OF 294MG/DL FASTING. NOTE 2: MANUFACTURER CONTACTED CUSTOMER ON A FOLLOW-UP CALL ON 22-MAR-2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HIS CONDITION HAD IMPROVED AND HE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. NO MEDICAL INTERVENTION SINCE THE LAST CALL HAD BEEN REQUIRED. CUSTOMER HAD TESTED AND OBTAINED A BLOOD GLUCOSE TEST RESULT OF 206MG/DL FASTING USING THE TRUE METRIX METER. REPLACEMENT PRODUCTS WERE SENT TO CUSTOMER. NOTE: 3: CUSTOMER CONTACTED MANUFACTURER ON ON31-MAR-2021 TO INFORM CUSTOMER IS SATISFIED AND WANTS TO KEEP THE ORIGINAL METER. CUSTOMER SAW DOCTOR ON (B)(6) 2021 WHERE HE WAS DIAGNOSED WITH DIABETES. NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED AND NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-2 ERROR. SISTER IS CALLING ON BEHALF OF THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). AT THE TIME OF THE CALL, THE CUSTOMER WAS CURRENTLY IN THE ER DUE TO SYMPTOMS OF BLURRY VISION AND DRY MOUTH. SISTER STATED SHE HAD CONTACTED CUSTOMER'S DOCTOR AND HAD BEEN ADVISED TO GO TO THE ER. SISTER STATED CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL HAD BEEN 491MG/DL (FASTING/NON-FASTING UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561941 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL ZX4168S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization