BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8685487 · Received June 10, 2019

    Report

    Report Number
    1000113657-2019-00598
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 10, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT: # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58 -USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER SYMPTOMS IMPROVED AND REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATES THAT THE METER IS NOT ACCURATE. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER MEMORY OF 123, 109, 142, 122 AND 163 MG/DL. THE CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING WEAK AND BELIEVED IT TO BE DUE TO HIS BLOOD SUGAR. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER REPORTED A PAST ADVERSE EVENT. CUSTOMER STATED ON (B)(6) 2019, HE HAD FELT WEAK AND HAD PASSED OUT. 911 HAD BEEN CALLED AND CUSTOMER HAD BEEN TAKEN TO THE HOSPITAL. CUSTOMER DID NOT KNOW WHAT HIS BLOOD GLUCOSE TEST RESULT WAS WHEN THE AMBULANCE HAD ARRIVED OR WHEN AT THE HOSPITAL. THE CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS AND PANCREATITIS AND HAD BEEN IN THE ICU. CUSTOMER WAS GIVEN FLUIDS, VITAMIN B AND LITHIUM CARBONATE. CUSTOMER STATED WHILE IN THE HOSPITAL HE HAD FELT WEAK AND ALSO HAD DIARRHEA. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2019 WITH A LIST OF NEW MEDICATIONS AND NEEDED TO FOLLOW UP WITH HIS DOCTOR. CUSTOMER STATED THAT HE HAD FOLLOWED UP WITH HIS PRIMARY CARE DOCTOR ON (B)(6) 2019. CUSTOMER STATED AT THE DOCTOR'S THEY HAD PERFORMED TWO BLOOD TESTS AND THAT THE RESULTS WITH THEIR METER WERE 20-40 POINTS HIGHER. ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 150 MG/DL AND E-3 USING THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478424 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2774

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization