BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE BC-GP NUCLEIC ACID TEST KIT

    MDR report key: 19542597 · Received June 14, 2024

    Report

    Report Number
    3006028115-2024-00011
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 14, 2024
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    PAM
    UDI-DI
    00840487101575
    PMA / PMN Number
    K122514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH INVESTIGATION THE CAUSE OF THE REPORTED FALSE POSITIVE STAPHYLOCOCCUS LUDGUNESIS RESULT IS UNDETERMINED. FURTHER INVESTIGATION FOR ROOT CAUSE WILL BE DOCUMENTED IN ESCALATION CASE (B)(4) AND (B)(4). THE CUSTOMER SITE IS NOT PERFORMING WITHIN THE EXPECTATIONS STATED IN THE BC-GP PACKAGE INSERT FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET. ALTHOUGH THE ERRONEOUS RESULT OCCURRED, THERE WAS NO INJURY OR DEATH TO PATIENT.

    Description of Event or Problem · 0

    ON 5/15/2024 CUSTOMER (B)(6) MEDICAL CENTER REPORTED A DISCREPANT RESULT ON BC-GP ASSAY. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER REPEAT TESTING SHOWED STREPTOCOCCUS AGALACTIAE DETECTED. VERIGENE RUN 1: STAPHYLOCOCCUS LUDGUNESIS DETECTED. VERIGENE RUN 2: STREPTOCOCCUS AGALACTIAE DETECTED. DATA REVIEW. PER VERIGENE ID SOFTWARE REQUIREMENTS SPECIFICATION (TOAST-SRS-1042), IN ORDER FOR AN ORGANISM TO BE DETECTED THE IC RATIO MUST BE GREATER THAN OR EQUAL TO -0.4 AND THE NC RATIO MUST BE GREATER THAN 0.85. REVIEW OFTEST CARTRIDGE 01866676 SHOWS STAPHYLOCOCCUS LUDGUNESIS WAS DETECTED AT EXPOSURE 150 (IC: -0.3 NC: 0.88) WITH NO OTHER ELEVATED SIGNALS. PCL WAS DETECTED AT EXPOSURE 24 (IC: 0.29 NC: 0.96) AND PC 2 WAS DETECTED AT EXPOSURE 24 WITH IC AND NC VALUES OF 0.25 AND 0.96 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH NO IMPACT ON RESULTS. THIS WAS TESTED ON 5/6/2024 ON SP A2. CONSUMABLE REVIEW TEST CARTRIDGE LOT: 031824018A EXTRACTION TRAY LOT: 032524018B UTILITY TRAY LOT: LOT INFORMATION NOT AVAILABLE THERE ARE NO NCMRS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE TEN OTHER ERRONEOUS RESULTS REPORTED FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET USING THE LOTS REPORTED. DUE TO THE AMOUNT OF COMPLAINTS, FURTHER INVESTIGATION OF TEST CARTRIDGE LOT 031824018A WILL BE DOCUMENTED IN ESCALATION CASE 01459590 AND HRA-24-0007. DEVICE REVIEW VERIGENE PROCESSOR SP A2: 18318004 VERIGENE READER: 18240003 REVIEW OF THE VERIGENE SP AND READER DEVICE HISTORY WAS ASSESSED FOR A TIME FRAME OF 3 MONTHS PRIOR TO THE REPORTED DISCREPANT RESULT. VERIGENE SP S/N 19325005 HAD NO WORK PERFORMED ON THIS DEVICE THERE IS ONE OTHER ERRONEOUS RESULTS FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET ON SP A2. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. VERIGENE READER 18240003 HAD NO WORK PERFORMED IN THE PAST 3 MONTHS. THERE WAS NO WORK PERFORMED DURING THIS TIMEFRAME. FURTHER INVESTIGATION WILL BE DOCUMENTED IN ESCALATION CASE (B)(4) AND (B)(4). SITE PERFORMANCE A 6 MONTH CUSTOMER SITE PERFORMANCE FOR NEGATIVE AGREEMENT OF STAPHYLOCOCCUS LUDGUNESIS TARGET WAS PERFORMED FROM NOV/2023 TO MAY/2024. THERE WAS A NEGATIVE AGREEMENT OF 99.0% (684 NOT DETECTED/691 EXPECTED NOT DETECTED). PER THE VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST PACKAGE INSERT (89-30000-00-782) THE EXPECTED NEGATIVE AGREEMENT FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET IS 100% (WITH A CL OF 99.7-99.9). FURTHER INVESTIGATION WILL BE DOCUMENTED IN ESCALATION CASE (B)(4) AND (B)(4). CONCLUSION THROUGH INVESTIGATION THE CAUSE OF THE REPORTED FALSE POSITIVE STAPHYLOCOCCUS LUDGUNESIS RESULT IS UNDETERMINED. FURTHER INVESTIGATION FOR ROOT CAUSE WILL BE DOCUMENTED IN ESCALATION CASE (B)(4) AND (B)(4). THE CUSTOMER SITE IS NOT PERFORMING WITHIN THE EXPECTATIONS STATED IN THE BC-GP PACKAGE INSERT FOR THE STAPHYLOCOCCUS LUDGUNESIS TARGET. ALTHOUGH THE ERRONEOUS RESULT OCCURRED, THERE WAS NO INJURY OR DEATH TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784690 VERIGENE BC-GP NUCLEIC ACID TEST KIT VERIGENE BC-GP ASSAY PAM LUMINEX CORPORATION 031824018A 00840487101575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown