BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL RESPIRATORY HEALTH TEST

    MDR report key: 19055915 · Received April 5, 2024

    Report

    Report Number
    3016608638-2024-00003
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 3, 2024
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS USING EXTERNAL CONTROL SWABS TO COLLECT PATIENT SPECIMENS INSTEAD OF PATIENT SWABS. POSITIVE CONTROL SWABS ARE EXPECTED TO YIELD POSITIVE RESULTS FOR ALL THREE MARKERS (FLU A, FLU B, AND COVID-19) ON THE VISBY RESPIRATORY TEST. THE DEVICES IN QUESTION OPERATED AS INTENDED. ON PAGE 4 OF THE INSTRUCTIONS FOR USE (IFU), UNDER MATERIALS REQUIRED BUT NOT PROVIDED, "SWAB" IS LISTED AND ADDITIONALLY INSTRUCTS THE USER TO USE A STERILE NYLON, FOAM, OR POLYESTER FLOCKED FLEXIBLE SHAFT SWAB ONLY. RESPIRATORY HEALTH POSITIVE AND NEGATIVE EXTERNAL CONTROL SWABS ARE LISTED AS MATERIALS REQUIRED AND AVAILABLE AS ACCESSORIES. THE CUSTOMER HAS PLACED AN ORDER FOR PATIENT SWABS TO USE TO COLLECT SPECIMENS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. 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.

    Description of Event or Problem · 0

    THE CUSTOMER NOTIFIED VISBY THAT THEY RAN A PATIENT SAMPLE ON A VISBY RESPIRATORY TEST AND RECEIVED A POSITIVE RESULT FOR ALL THREE MARKERS (FLU A, FLU B, AND COVID-19). THE CUSTOMER RAN A SECOND VISBY RESPIRATORY TEST WITH THE SAME VISBY RESPIRATORY HEALTH BUFFER SAMPLE AND RECEIVED POSITIVE RESULTS FOR ALL THREE MARKERS. THE CUSTOMER RE-SWABBED THE PATIENT AND SENT THE NEW SAMPLE TO A THIRD PARTY LAB, (B)(6). RESULTS OF THE (B)(6) TEST WAS REQUESTED BUT NOT PROVIDED. AN INVESTIGATION DETERMINED THAT THE CUSTOMER WAS USING THE POSITIVE EXTERNAL CONTROL (QC) SWAB (RESPIRATORY HEALTH CONTROL SWAB) TO COLLECT THE PATIENT SAMPLE INSTEAD OF A NASOPHARYNGEAL OR ANTERIOR NASAL NYLON, FOAM, OR POLYESTER FLOCKED FLEXIBLE SHAFT SWAB AS INSTRUCTED. NO HARM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758285 VISBY MEDICAL RESPIRATORY HEALTH TEST VISBY MEDICAL RESPIRATORY HEALTH TEST QLT VISBY MEDICAL, INC. PS-300708 LN24020071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EXTERNAL CONTROL SWAB KIT.PS-400381.