BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE PROCESSOR SP

    MDR report key: 14366005 · Received May 11, 2022

    Report

    Report Number
    1650733-2022-00027
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    January 21, 2022
    Report Date
    May 10, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    NSU
    UDI-DI
    00840487101483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL ASSOCIATED CUSTOMER-PROVIDED DOCUMENTATION AND INTERNALLY GENERATED INVESTIGATION NOTES AGAINST THE CRITERIA SET FORTH IN DOCUMENT 00043 (MEDICAL DEVICE REPORTING STANDARDS OPERATING PROCEDURE), THIS COMPLAINT DOES MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE THIS PRODUCT IS SOLD OR DISTRIBUTED. FILING INDIVIDUAL MDR OUT OF ABUNDANCE OF CAUTION DUE TO THE REMOTE POSSIBILITY OF A FALSE RESULT CONTRIBUTING TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    THE SERVICE VISIT AT (B)(6) MEDICAL CENTER WAS SCHEDULED PER CAPA (B)(4) WITHIN WORK ORDER (B)(4). DURING THE SITE VISIT, THE HYBRIDIZATION (HYB) HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINT 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURE FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT (03838). DATA REVIEW: PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT (03768),THE STUDY EVALUATED ASSAY PERFORMANCE OF VERIGENE® RP FLEX, EP, CDF, BC-GP AND BC-GN ASSAYS AT VARYING CRITICAL TEMPERATURE PARAMETERS AND ESTABLISHED A FUNCTIONAL RANGE OF TEMPERATURE FOR ASSAY TOLERANCE ABOVE AND BELOW THE NOMINAL SET POINTS. IT WAS DETERMINED WITHIN 03838, THAT THE HYB HEATER HAS AN UPPER AND LOWER TOLERANCE OF +/-2 DEGREE CELSIUS FROM THE SETPOINT TEMPERATURE 1 (38.5C) AND SETPOINT 2 (90C). IN REVIEWING THE NAPLOGS, SETPOINT 1 FOR THE HYB HEATER WAS WITHIN THE ACCEPTABLE TEMPERATURE RANGE VERIFICATION TESTING. PER THE VERIGENE PROCESSOR SP SYSTEM DESIGN FMEA (NAPIII-FMEA-1729), THE SYSTEM WILL MONITOR TEMPERATURE THROUGHOUT THE PROCEDURE. ONCE AT TEMPERATURE, THE SYSTEM MUST MAINTAIN THE TARGET TEMPERATURE WITHIN +/- 1C, OR THE SYSTEM WILL ALARM AND TERMINATE THE PROCEDURE VIA THE HARDWARE/SOFTWARE. HOWEVER, SETPOINT 2 HAD AN ADJUSTED TEMPERATURE OF +92.3C, 0.3C HIGHER THAN THE ACCEPTABLE RANGE PER 03838. DUE THE FINDING, RISK ASSESSMENT QUESTION 2 WAS UPDATED TO 'YES'. SITE PERFORMANCE: THE CUSTOMER SITE IS CURRENTLY RUNNING THE BC-GP AND BC-GN VERIGENE ASSAYS. REVIEW OF ASSOCIATED COMPLAINT CASES SHOWS A SINGLE REPORTED FALSE RESULT REPORTED FOR THIS SP PROCESSOR IN THE PAST 18 MONTHS. IT SHOULD BE NOTED THAT THIS FALSE NEGATIVE RESULT WAS REPORTED WHEN UTILIZING A 3RD PARTY CONTRIVED QUALITY CONTROL MATERIAL. PER THE BC-GP PACKAGE INSERT (89-30000-00-782) THE PERFORMANCE CHARACTERISTICS OF THE VERIGENE BLOOD CULTURE ASSAY WAS ESTABLISHED USING BLOOD THAT HAS BEEN DRAWN ASEPTICALLY INTO BLOOD CULTURE BOTTLES AND SUBSEQUENTLY GROWN ON A BLOOD CULTURE MONITORING SYSTEM. THE PERFORMANCE CHARACTERISTICS OF THIRD PARTY MATERIAL USING THE VERIGENE SYSTEM HAS NOT BEEN FULLY EVALUATED, THEREFORE THE PERFORMANCE CHARACTERISTICS ARE NOT ESTABLISHED. CONCLUSION: THE CUSTOMER SITE REPORTED NO PATIENT SAMPLE FALSE RESULTS FOR THE SP PROCESSOR S/N (B)(4). THERE IS NO INDICATION OF THIS VERIFICATION FAILURE RESULTING IN AN ADVERSE EFFECT TO PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171418 VERIGENE PROCESSOR SP VERIGENE PROCESSOR SP NSU LUMINEX CORPORATION 10-0000-07 11250096 00840487101483

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown