BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL RESPIRATORY HEALTH TEST

    MDR report key: 19255491 · Received May 6, 2024

    Report

    Report Number
    3016608638-2024-00004
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 6, 2024
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES AND CONTROLS WERE REQUESTED BACK FOR EVALUATION BUT HAVE NOT YET BEEN RECEIVED. ONCE THE DEVICE AND CONTROL ARE RECEIVED AND/OR INVESTIGATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. D10: LOT: 23227215 C4: TREATMENT/ THERAPY START AND STOP DATES (USE BLOCK C4 TO RECORD THE DATE THAT A DIAGNOSTIC TEST WAS PERFORMED FOR REPORTS THAT INVOLVE AN IN VITRO DIAGNOSTIC PRODUCT.) START DATE: (B)(6) 2024 STOP DATE: (B)(6) 2024.

    Additional Manufacturer Narrative · 0

    (B)(6) 2024, (B)(6): ATTEMPT 1 FOR SUBMISSION, FAILED DUE TO ETQ ERRORS. (B)(6) 2024, (B)(6): ATTEMPT 2 FOR SUBMISSION, FAILED DUE TO ETQ ERRORS. (B)(6) 2024, (B)(6): ATTEMPT 3 FOR SUBMISSION. THE DEVICE WAS INVESTIGATED BY THE VISBY FAILURE INVESTIGATION TEAM (FIT) ENGINEER AND THE VISBY CORE LAB TEAM. THE INVESTIGATION PROCEDURE INVOLVES EXAMINING THE FINAL POSITION OF THE VARIOUS DEVICE COMPONENTS, TESTING OTHER COMPONENTS FOR CORRECT FUNCTION, AND TESTING THE WASTE LIQUID REAGENT TO ASSESS FOR PCR PERFORMANCE, IF NECESSARY. WHILE THE DEVICE HAD LOWER WASTE VOLUME IN THE FINAL TEST THAN EXPECTED, BASED ON THE WASTE LIQUID REAGENT, THE PCR PROCEEDED AS EXPECTED. THEREFORE, IT WAS CONCLUDED THAT A DEVICE ISSUE OCCURRED DURING THE SPOT DEVELOPMENT PORTION OF THE DEVICE RUN. UPDATED FIELDS: B4. DATE OF THIS REPORT. D9. DEVICE AVAILABILITY. G3. DATE RECEIVED BY MANUFACTURER. G6. TYPE OF REPORT. H2. IF FOLLOW-UP, WHAT TYPE. H3. DEVICE EVALUATED BY MANUFACTURER. H6. TYPE OF INVESTIGATION. H6. INVESTIGATION FINDINGS. H6. INVESTIGATION CONCLUSIONS. H11. MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER RECEIVED A NEGATIVE RESULT FOR INFLUENZA B FROM THE VISBY MEDICAL RESPIRATORY HEALTH TEST WHEN RUNNING THE POSITIVE EXTERNAL CONTROL SWAB. VISBY CANNOT ASSESS THE ROOT CAUSE OF THE ALLEGED NEGATIVE RESULT AS THE CUSTOMER HAS NOT RETURNED THE VISBY TEST. NO HARM WAS ALLEGED, AND NO PATIENT SAMPLES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613108 VISBY MEDICAL RESPIRATORY HEALTH TEST VISBY MEDICAL RESPIRATORY HEALTH TEST QLT VISBY MEDICAL, INC. PS-300708 LN24030190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown (B)(4).RESPIRATORY HEALTH CONTROL SWABS