BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 4974088 · Received August 5, 2015

    Report

    Report Number
    3022521-2015-00001
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    May 27, 2015
    Report Date
    July 20, 2015
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K092353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTIONS WERE TAKEN TO ENSURE THAT PASSING PERFORMANCE EVALUATIONS ARE OBTAINED PRIOR TO RELEASE OF INSTRUMENTS FOR CUSTOMER USE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BIO-RAD TECHNICAL SUPPORT FOR INVALID RUNS WITH MULTIPLE ASSAYS AND UPON INVESTIGATING TECHNICAL SUPPORT OBTAINED INFORMATION THAT AFTER A SERVICE CALL ON (B)(6) 2015 A BIO-RAD LABORATORIES FIELD SERVICE ENGINEER HAD RELEASED AN EVOLIS INSTRUMENT TO THE CUSTOMER WITH A "PERFORMANCE EVALUATION (PE)" THAT DID NOT PASS. THE PE PIPETTOR PRECISION HAD NOT PASSED. A PASSING PERFORMANCE EVALUATION ON THE EVOLIS IS REQUIRED BEFORE RELEASE FOR PATIENT TESTING. UPON RETESTING SAMPLES RUN DURING THIS PERIOD IT WAS DETERMINED NO INCORRECT RESULTS WERE REPORTED IN REGARDS TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517603 EVOLIS MICROPLATE SYSTEM 4 PS SYSTEM JJE BIO-RAD LABORATORIES EVOLIS

    Patients

    Seq Age Sex Outcome Treatment
    1