BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETEST

    MDR report key: 12233560 · Received July 27, 2021

    Report

    Report Number
    1000113657-2021-00456
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 30, 2021
    Report Date
    December 10, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 10-DEC-2021: H10: TEST STRIP LOT NUMBER IS EXPIRED - UNABLE TO PERFORM RETENTION TESTING. ROOT CAUSE: RC-074: MANUFACTURING PROCESSING ERROR.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). PRODUCT PROBLEM BEING SUBMITTED DUE TO TEST STRIPS BEING PART OF RECALL # 1052693-06/13/16-001-R. METER AND TEST STRIPS WERE RETURNED, NO INVESTIGATION REQUIRED: TEST STRIPS ARE EXPIRED AND NO PRODUCT COMPLAINT WAS ALLEGED BY THE CUSTOMER. NOTE: MANUFACTURER WAS UNABLE TO ESTABLISH CONTACT WITH CUSTOMER; CUSTOMER DID NOT PROVIDE TELEPHONE NUMBER.

    Description of Event or Problem · 1

    CONSUMER RETURNED THE TRUERESULT METER AND TRUETEST TEST STRIPS WITH A LETTER ASKING TO RECYCLE THE PRODUCTS. CUSTOMER DID NOT REPORT COMPLAINT REGARDING THE PRODUCTS AND STATED IT WAS BEING RETURNED DUE TO NO LONGER NEEDING TO TEST HER BLOOD GLUCOSE. THE PRODUCT IS DISCONTINUED AND EXPIRED - THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 05/18/21018 AND TEST STRIPS ARE PART OF RECALL. CUSTOMER DID NOT STATE IN HER LETTER THAT ANY MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT HAD BEEN REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132852 TRUETEST SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, MCK MED-SURG 50CTTRUETEST PS2317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown