BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY, RESPIRATORY HEALTH DEVICE, POC

    MDR report key: 17881368 · Received October 5, 2023

    Report

    Report Number
    3016608638-2023-00008
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 25, 2023
    Report Date
    September 25, 2023
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    04 OCTOBER 2023, (B)(4). VISBY HAS DETERMINED THAT THE ANSWER TO THE MDR DECISION TREE QUESTIONS ARE ALL "NO." HOWEVER, VISBY UNDERSTANDS THAT THIS EVENT SHOULD BE REPORTED TO THE FDA PER THE EUA CONDITIONS OF AUTHORIZATIONS. THEREFORE, A MEDWATCH IS BEING SUBMITTED FOR THIS EVENT. THE POSITIVE RESULTS FOR ALL THREE MARKERS OF THE VISBY RESPIRATORY HEALTH TEST ((FLU A, BLU B, AND COVID-19) WAS CONFIRMED VIA THE PHOTOGRAPH PROVIDED BY THE CUSTOMER. THE CUSTOMER DISCARDED THE VISBY TEST. SINCE THE DEVICE COULD NOT BE RETURNED, THE ROOT CAUSE OF THE POSITIVE RESULTS FOR ALL THREE MARKERS COULD NOT BE DETERMINED. ON PAGES 15-16 OF THE INSTRUCTIONS FOR USE (IFU) IT STATES UNDER LIMITATIONS, "3. CROSS-REACTIVITY WITH RESPIRATORY TRACT ORGANISMS OTHER THAN THOSE TESTED IN THE ANALYTICAL SPECIFICITY STUDY MAY LEAD TO ERRONEOUS RESULTS;" "6. ERRONEOUS RESULTS MAY OCCUR FROM IMPROPER SPECIMEN COLLECTION, TECHNICAL ERROR, SAMPLE MIX-UP, OR IF THE VIRAL LOAD IN THE PATIENT SAMPLE IS BELOW THE LIMIT OF DETECTION OF THE VISBY MEDICAL RESPIRATORY HEALTH TEST;" "7. CAREFUL COMPLIANCE WITH THE INSTRUCTIONS IN THIS INSERT AND THE QUICK REFERENCE GUIDE INSTRUCTIONS ARE NECESSARY TO AVOID INACCURATE RESULTS;" AND "19. RECENT PATIENT EXPOSURE TO FLUMIST® OR OTHER LIVE ATTENUATED INFLUENZA VACCINES MAY CAUSE INACCURATE POSITIVE RESULTS." ADDITIONALLY THROUGHOUT THE IFU ARE EXAMPLES OF PRACTICES THAT COULD LEAD TO INACCURATE RESULTS (PG 7, POINT 10 UNDER SPECIMEN; PG 8, WARNING UNDER SPECIMEN COLLECTION AND STORAGE; AND PG 10, STEP A UNDER MIX AND ADD PATIENT SAMPLE). THERE WILL BE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME AS THE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. VISBY WILL CONTINUE TO MONITOR FOR TRENDS. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION D4: (B)(4).

    Description of Event or Problem · 0

    THE PHYSICIAN COLLECTED AN ANTERIOR NASAL (AN) SAMPLE FROM THE PATIENT AND USED A VISBY RESPIRATORY HEALTH TEST. THE PATIENT SAMPLE RECEIVED POSITIVE RESULTS FOR ALL THREE (3) MARKERS ON THE VISBY TEST (FLU A, FLU B, AND COVID-19). THE CUSTOMER ADVISED THEY FOLLOWED THE QUICK REFERENCE GUIDE (QRG) AND COMPLETED THEIR DECONTAMINATION PRACTICE PRIOR TO RUNNING THE VISBY TEST. THE CUSTOMER RAN A NEW PATIENT SAMPLE ON A MOLECULAR COMPARATOR TEST AND THE SAMPLE RECEIVED NEGATIVE RESULTS FOR FLU A, FLU B, AND COVID-19.

    Description of Event or Problem · 0

    CUSTOMER RAN VISBY TEST AND PATIENT SAMPLE WAS POSITIVE FOR ALL MARKERS. THE CUSTOMER RAN THE TEST AGAINST A BIOFIRE MACHINE AND PATIENT WAS ONLY POSITIVE FOR RHINO/ENTERO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063645 ASSEMBLY, RESPIRATORY HEALTH DEVICE, POC RESPIRATORY HEALTH TEST QLT VISBY MEDICAL, INC. PS-300708 LN23080050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown