BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 9774316 · Received March 2, 2020

    Report

    Report Number
    1000113657-2020-00119
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 30, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF (B)(6) 2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION 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 AND PASSED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18: USER HAS HIGH GLUCOSE VALUE. CUSTOMER CALLED BACK ON (B)(6) 2020 AND REQUESTED TO HAVE PRODUCT REPLACED. DURING FOLLOW-UP CALL ON 13-FEB-2020, CUSTOMER STATED THAT SHE RECEIVED MEDICAL ATTENTION SINCE THE INITIAL CALL. CUSTOMER STATED THAT ON (B)(6) 2020, 911 HAD BEEN CALLED AND SHE HAD BEEN TAKEN TO THE EMERGENCY ROOM VIA AMBULANCE. CUSTOMER STATED THE DAY BEFORE, (B)(6) 2020, SHE HAD BEEN TO HER REGULAR DOCTOR VISIT AND HER BLOOD GLUCOSE TEST RESULT WAS OVER 700 MG/DL. CUSTOMER'S PHYSICIAN ADVISED HER TO GO TO THE HOSPITAL. CUSTOMER STATED THAT SHE HAD WAITED UNTIL THE NEXT DAY, (B)(6) 2020, WHEN SHE HAD STARTED TO FEEL WOOZY AND THEN CALLED 911. CUSTOMER COULD NOT RECALL HER BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL. CUSTOMER WAS DIAGNOSED WITH HIGH BLOOD GLUCOSE AND HAD RECEIVED INSULIN. CUSTOMER DID NOT RECALL THE DATE SHE WAS DISCHARGED; CUSTOMER WAS ADVISED BY A NEW PRIMARY CARE PHYSICIAN, A HEART SPECIALIST, AND DIABETES TRAINING. AT THE TIME OF THE FOLLOW-UP CALL ON 13-FEB-2020, THE CUSTOMER DID NOT REPORT HAVING ANY DIABETIC SYMPTOMS.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. CUSTOMER HAD JUST PURCHASED THE METER ON DAY OF CALL, (B)(6) 2020. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF HI. THE CUSTOMER DOES NOT KNOW HER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF HI USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM AND LIVING AREA. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2021 AND OPEN VIAL DATE IS 02/04/2020. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. THE CUSTOMER HAD BEEN SATISFIED AFTER TROUBLESHOOTING AT THE TIME OF THE INITIAL CALL AND HAD DECLINED A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240204 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMT 30CT24/CASE MG/DL MW3503S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention