BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL RESPIRATORY HEALTH TEST

    MDR report key: 18522069 · Received January 16, 2024

    Report

    Report Number
    3016608638-2024-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 24, 2023
    Report Date
    January 8, 2024
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEGATIVE RESULT FOR INFLUENZA A FROM THE VISBY MEDICAL RESPIRATORY HEALTH TEST COULD NOT BE CONFIRMED AS THE CUSTOMER DISCARDED THE VISBY TEST AND THE SPECIMEN TESTED WITH THE VISBY TEST. SINCE THE SPECIMEN AND DEVICE COULD NOT BE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE ALLEGED NEGATIVE RESULTS COULD NOT BE DETERMINED. POTENTIAL CAUSES OF FALSE NEGATIVE RESULTS INCLUDE, BUT ARE NOT LIMITED TO: LOW VIRAL LOAD (BELOW THE LIMIT OF DETECTION), IMPROPER SPECIMEN COLLECTION, TECHNICAL ERROR, SAMPLE MIX-UP, AND/OR NON-COMPLIANCE WITH INSTRUCTIONS. 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). 2023 STOP DATE: (B)(6). 2023.

    Description of Event or Problem · 0

    THE CUSTOMER RECEIVED A NEGATIVE RESULT FOR INFLUENZA A FROM THE VISBY MEDICAL RESPIRATORY HEALTH TEST. THE CUSTOMER SENT A DIFFERENT SAMPLE FROM THE SAME PATIENT TO ANOTHER LAB WHICH RETURNED A POSITIVE RESULT FOR INFLUENZA A. THE CUSTOMER ALLEGES THE RESULT FROM THE VISBY TEST IS A FALSE NEGATIVE. THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION ON THE SECOND TEST, AND VISBY CANNOT CONFIRM THE RESULT FROM THE INITIAL TEST OR ASSESS THE ROOT CAUSE OF THE ALLEGED NEGATIVE RESULT AS THE CUSTOMER DISCARDED THE VISBY TEST. NO HARM WAS ALLEGED, AND THE INITIAL RESULT FROM THE VISBY TEST WAS NOT RELEASED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818483 VISBY MEDICAL RESPIRATORY HEALTH TEST RESPIRATORY HEALTH TEST QLT VISBY MEDICAL, INC. PS-300708 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown