BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE BC-GP NUCLEIC ACID TEST KIT

    MDR report key: 19817898 · Received July 24, 2024

    Report

    Report Number
    3006028115-2024-00016
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 23, 2024
    Report Date
    July 24, 2024
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    PAM
    UDI-DI
    00840487101575
    PMA / PMN Number
    K122514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH INVESTIGATION THE CAUSE OF THE REPORTED FALSE POSITIVE STAPHYLOCOCCUS LUDGUNESIS RESULT WILL BE INVESTIGATED UNDER (B)(4). FURTHER INVESTIGATION FOR ROOT CAUSE WILL BE DOCUMENTED IN ESCALATION CASE (B)(4). ALTHOUGH THE ERRONEOUS RESULT OCCURRED, THERE WAS NO NOTED INJURY OR ADVERSE HEATH CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    ON 6/23/2024 CUSTOMER (B)(6) MEDICAL CENTER BROWNWOOD REPORTED A DISCREPANT RESULT ON BC-GP ASSAY IN RESPONSE TO FSN-0005. VERIGENE DETECTED STAPHYLOCOCCUS LUGDUNENSIS, HOWEVER MALDI-TOF DETECTED CORYNEBACTERIUM STRIATUM. VERIGENE: STAPHYLOCOCCUS LUDGUNESIS AND ENTEROCOCCUS FAECIUM DETECTED. CULTURE: STREPTOCOCCUS GALLOLYTICUS DETECTED. MALDI-TOF: CORYNEBACTERIUM STRIATUM 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 OF TEST CARTRIDGE (B)(4) SHOWS STAPHYLOCOCCUS LUDGUNESIS DETECTED AT EXPOSURE 1200MS (IC: -0.28 NC: 0.87). PC1 WAS DETECTED AT EXPOSURE 24MS (IC: 0.53 NC: 0.99) AND PC 2 WAS DETECTED AT EXPOSURE 24MS WITH IC AND NC VALUES OF 0.23 AND 0.98 RESPECTIVELY. CAMERA IMAGES WERE CLEAR WITH SUSPECTED NO IMPACT ON RESULTS. TEST WAS COMPLETED ON (B)(6) 2024. CONSUMABLE REVIEW: TEST CARTRIDGE LOT: 031824018A. EXTRACTION TRAY LOT: 031124018B. UTILITY TRAY LOT: 030824018C. THERE ARE NO NCS ASSOCIATED WITH THE LOTS UTILIZED. THERE ARE 25 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 (B)(4) AND HRA-24-0007. DEVICE REVIEW: VERIGENE PROCESSOR SP: 18054001. VERIGENE READER: 22243901. 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 PROCESSOR SP AND READER EACH HAD ONE PM PERFORMED WITHOUT ISSUE. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. SITE PERFORMANCE: A 6-MONTH CUSTOMER SITE PERFORMANCE FOR NEGATIVE AGREEMENT OF STAPHYLOCOCCUS LUDGUNESIS TARGET WAS PERFORMED FROM (B)(6) 2024. THERE WAS A NEGATIVE AGREEMENT OF 99.3% (142 NOT DETECTED/143 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 CI OF 99.7-99.9). BASED ON THE EXPECTED PERFORMANCE CHARACTERISTICS AND DATA PROVIDED BY THE CUSTOMER, THE CUSTOMER SITE IS NOT PERFORMING WITHIN THE PACKAGE INSERT EXPECTATIONS, FURTHER INVESTIGATION OF TEST CARTRIDGE LOT 031824018A WILL BE DOCUMENTED IN ESCALATION (B)(4). CONCLUSION: THROUGH INVESTIGATION THE CAUSE OF THE REPORTED FALSE POSITIVE STAPHYLOCOCCUS LUDGUNESIS RESULT WILL BE INVESTIGATED UNDER (B)(4). FURTHER INVESTIGATION FOR ROOT CAUSE WILL BE DOCUMENTED IN ESCALATION CASE (B)(4). ALTHOUGH THE ERRONEOUS RESULT OCCURRED, THERE WAS NO NOTED INJURY OR ADVERSE HEATH CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356995 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