BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE PROCESSOR SP

    MDR report key: 14311544 · Received May 6, 2022

    Report

    Report Number
    1650733-2022-00021
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    January 20, 2022
    Report Date
    May 5, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    NSU
    UDI-DI
    00840487101483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 (B)(4) (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 KATHERINE (B)(6) HOSPITAL. WAS SCHEDULED PER CAPA-21-014 WITHIN WORK ORDER WO-00199948. DURING THE SITE VISIT, THE ELUTION HEATER REQUIRED RECALIBRATION DUE TO FAILING INITIAL VERIFICATION AT SETPOINTS 1 AND 2. FIELD QUALITY UPDATED RISK ASSESSMENT QUESTION 2 TO 'YES' SINCE THE SETPOINT TEMPERATURES FAILED OUTSIDE THE ACCEPTED LIMITS ESTABLISHED BY THE VERIGENE I ASSAY TEMPERATURE TOLERANCE GUARD BAND RISK REPORT ((B)(4)). PER THE VERIGENE ASSAY TEMPERATURE TOLERANCE (GUARD-BAND) STUDY REPORT ((B)(4)), THE STUDY EVALUATED THE 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 (B)(4), THAT THE ELUTION HEATER HAS A LOWER TOLERANCE OF -4DEGREE CELSIUS AND AN UPPER TOLERANCE OF GREATER THAN OR EQUAL TO 5DEGREE FROM THE SETPOINT TEMPERATURE 1 (75.0C) AND SETPOINT 2 (85.0C). IN REVIEWING THE ATTACHED NAPLOGS, SETPOINT 1 FOR THE ELUTION HEATER HAD AN ADJUSTED TEMPERATURE OF +86.1C AND SETPOINT 2 HAD AN ADJUSTED TEMPERATURE OF +97.9C; BOTH HIGHER THAN THE ACCEPTABLE RANGE PER (B)(4). DUE THE FINDING, RISK ASSESSMENT QUESTION 2 WAS UPDATED TO 'YES'. THE CUSTOMER SITE IS CURRENTLY RUNNING BC-GP, BC-GN, AND EP VERIGENE ASSAYS. THE ELUTION HEATER VERIFICATION FAILURE CAN POTENTIALLY IMPACT ASSAY PERFORMANCE FOR ALL THREE ASSAYS RAN AT THE CUSTOMER SITE PER (B)(4). WITHIN AN 18-MONTH TIMEFRAME FROM THE VERIFICATION FAILURE, THE CUSTOMER SITE HAS NOT REPORTED ANY PATIENT SAMPLE FALSE RESULTS ON EITHER ASSAY. THE CUSTOMER SITE REPORTED NO 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
    889467 VERIGENE PROCESSOR SP VERIGENE PROCESSOR SP NSU LUMINEX CORPORATION 10-0000-07 18128002 00840487101483

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown