BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL COVID-19 POINT OF CARE TEST

    MDR report key: 16456439 · Received February 28, 2023

    Report

    Report Number
    3016608638-2023-00006
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    December 16, 2021
    Report Date
    December 7, 2022
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2023, (B)(6): FIRST ATTEMPT TO SEND THE REPORT WAS MADE ON (B)(6) 2023; HOWEVER, IT FAILED TO RECEIVE SECOND AND THIRD ACKNOWLEDGMENTS. TICKET 349322 WITH THE EMDR HELP DESK WAS ISSUED. HELP DESK ADVISED TO RESUBMIT. SECOND ATTEMPT TO SEND THE REPORT WAS MADE ON (B)(6) 2023; HOWEVER, IT FAILED TO RECEIVE SECOND AND THIRD ACKNOWLEDGMENTS. TICKET 349523 WITH THE EMDR HELP DESK WAS ISSUED. HELP DESK ADVISED THEY RECEIVE AND ERROR WHEN TRYING TO PROCESS THE REPORT. ETQ IT DISCOVERED DISCREPANCY IN URL SERVLET. REQUEST SUBMITTED TO ESG HELP DESK FOR THE UPDATE TO THE CORRECT URL IN THE SERVLET. UPDATE WAS MADE ON TICKET 350943. THIS IS THE THIRD ATTEMPT TO SEND REPORT AFTER THE UPDATE. THE REPORTED EVENT IS CONSIDERED UNCONFIRMED AS IT HAS BEEN DETERMINED THAT THE DEVICE YIELDED A POSITIVE RESULT APPROPRIATELY. UPON INVESTIGATION, THE (B)(4) AMPLICON WAS FOUND INSIDE THE DEVICE. BASED ON THE VISUAL INSPECTION OF THE DEVICE COMPONENTS, THE DEVICE OPERATED AS INTENDED. THERE WILL BE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME AS THE COMPLAINT WAS NOT CONFIRMED. THE VISBY DEVICE THAT PRODUCED A NEGATIVE RESULT WAS ALSO RETURNED FOR EVALUATION. BASED ON THE VISUAL INSPECTION OF THE DEVICE COMPONENTS, THE DEVICE OPERATED AS INTENDED. UPON INVESTIGATION, THE (B)(4) N1 AMPLICON WAS NOT FOUND INSIDE THE DEVICE. THEREFORE, THE TEST RESULTS WERE A TRUE REFLECTION OF THE DEVICE CONTENTS. THE TARGET CONCENTRATION MAY HAVE BEEN AT OR BELOW THE DEVICE LIMIT OF DETECTION, WHICH WOULD LIKELY INCREASE THE PROBABILITY OF PRODUCING A NEGATIVE RESULT ON A VISBY POINT OF CARE TEST. PLEASE SEE PAGE 13 OF THE PACKAGE INSERT FOR INFORMATION ON THE ANALYTICAL SENSITIVITY (LIMIT OF DETECTION) OF OUR TESTS. 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. TREATMENT/ THERAPY START AND STOP DATES. START DATE: (B)(6)2021. STOP DATE: (B)(6) 2021.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE PATIENT CAME IN FOR TESTING AND RECEIVED A POSITIVE RESULT ON THE VISBY DEVICE. THE PATIENT WAS IMMEDIATELY RETESTED ON THE SAME DAY ON A SEPARATE VISBY DEVICE WHICH RETURNED A NEGATIVE RESULT. THE SAME SAMPLE WAS USED FOR BOTH VISBY TESTS. RESULTS FROM THE DEVICE EVALUATION CONFIRM THE VISBY DEVICES OPERATED AS INTENDED. THE CUSTOMER STATED THE PATIENT WAS BETWEEN TWENTY TO THIRTY YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196532 VISBY MEDICAL COVID-19 POINT OF CARE TEST VISBY MEDICAL COVID-19 TEST QJR VISBY MEDICAL, INC. PS-001260 LN21110092

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Unknown VISBY MEDICAL COVID-19 POWER ADAPTER(B)(4)