BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIGENE PROCESSOR SP

    MDR report key: 14700333 · Received June 15, 2022

    Report

    Report Number
    1650733-2022-00039
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 26, 2022
    Report Date
    June 14, 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 (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 (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 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608883 VERIGENE PROCESSOR SP VERIGENE PROCESSOR SP NSU LUMINEX CORPORATION 10-0000-07 00840487101483

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown