BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TMETRIX PR

    MDR report key: 7042506 · Received November 17, 2017

    Report

    Report Number
    1000113657-2017-01970
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 17, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    10612479210254
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND. QC INVESTIGATION ON 11/13/2017 RETURNED TEST STRIPS PRODUCE HIGH READINGS. MOST LIKELY UNDERLYING ROOT CAUSE OF HIGH CONTROL RESULTS ARE DUE TO IMPROPER STORAGE: VIAL LEFT OPEN FOR AN EXTENDED PERIOD OF TIME. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL GLUCOSE TEST RESULTS. HEALTHCARE PROVIDER FROM A HEALTHCARE FACILITY IS CALLING. THE CUSTOMER IS CONCERNED WITH CONTROL TEST RESULTS FROM RESULTS OBTAINED OF 65 AND 60 MG/DL. CONTROL TESTS NOT WITHIN ACCEPTABLE RANGE OF 25 - 55 MG/DL. CONTROL LEVEL ONE, LOT# 7BC1A20, MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN DATE IS (B)(6) 2017. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LAB AT THE FACILITY. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/23/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6) (HEALTHCARE PROVIDER) CALLING IN ON BEHALF OF (B)(6) CALLED IN STATES THE METER FOR CONTROL SOLUTIONS IS READING HIGH RESULT READ 65 MG/DL LEVEL 1 LOT#7BC1A20 RANGE 25MG/DL-55 MG/DL ALSO CONTROL SOLUTIONS IS READING HIGH RESULT READ 60 MG/DL LEVEL 1 LOT#7BC1A20 RANGE 25MG/DL-55 MG/DL. CONTROL SOLUTIONS AND TEST STRIPS WERE STORED IN LAB AND WEREN'T COMPROMISED. IT IS A FACILITY AND THEY WERE ADVISED TO DISCONTINUE THE USE OF THIS METER AND TEST STRIPS AND TO PLEASE RETURN SUPPLIES TO US FOR INVESTIGATION. WILL FOLLOW UP WITH FACILITY FOR CUSTOMER SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822875 TMETRIX PR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TMETRIX PR MU2365 10612479210254

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR