BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISBY MEDICAL COVID-19 POINT OF CARE TEST

    MDR report key: 16455860 · Received February 28, 2023

    Report

    Report Number
    3016608638-2023-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    October 6, 2021
    Report Date
    December 8, 2022
    Manufacturer
    VISBY MEDICAL, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    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 (B)(4) 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 (B)(4) 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 (B)(4). 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. BASED ON THE VISUAL INSPECTION OF THE DEVICE COMPONENTS, THE DEVICE OPERATED AS INTENDED. UPON INVESTIGATION, THE (B)(4) AMPLICON WAS FOUND INSIDE THE DEVICE. NO INVESTIGATION WAS PERFORMED ON THE DEVICE THAT RETURNED A NEGATIVE RESULT WITH THE SAME SAMPLE AS IT WAS DISCARDED BY THE CUSTOMER. THERE WILL BE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME AS THE COMPLAINT WAS NOT CONFIRMED. 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 (USE TO RECORD THE DATE THAT A DIAGNOSTIC TEST WAS PERFORMED FOR REPORTS THAT INVOLVE AN IN VITRO DIAGNOSTIC PRODUCT.) START DATE: (B)(6) 2021. STOP DATE: (B)(6) 2021.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT ONE VISBY DEVICE RETURNED A POSITIVE RESULT AND UPON RETESTING ON A SEPARATE VISBY DEVICE, RESULT WAS NEGATIVE. THE SAME SAMPLE WAS USED FOR BOTH TESTS. RESULTS FROM THE DEVICE EVALUATION CONFIRMS THE DEVICE THAT RETURNED A POSITIVE RESULT OPERATED AS INTENDED. THE DEVICE THAT PRODUCED A NEGATIVE RESULT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626957 VISBY MEDICAL COVID-19 POINT OF CARE TEST VISBY MEDICAL COVID-19 TEST QJR VISBY MEDICAL, INC. PS-001260 LN21080308

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Unknown VISBY MEDICAL COVID-19 POWER ADAPTERPS-000288