BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PR4100 MICROPLATE READER US

    MDR report key: 7386745 · Received March 30, 2018

    Report

    Report Number
    3022521-2018-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    February 17, 2018
    Report Date
    December 21, 2018
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJQ
    Removal / Correction Number
    3022521-4/2/2018-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL FROM A CUSTOMER STATING THAT THE D-LINK DUB-H4 USB HUB, USED WITH THE PR4100 MICROPLATE READER SYSTEM, STARTED SMOKING WHEN THE USER TURNED ON THE PR4100 COMPUTER. THE PR4100 MICROPLATE READER IS A 96-WELL ABSORBANCE READER FOR THE MEASUREMENT OF LIGHT ABSORBANCE (OPTICAL DENSITY-OD) OF LIQUID MEDIA. THE INSTRUMENT IS INTENDED TO BE USED PRIMARILY FOR IN VITRO DIAGNOSTIC ANALYSIS OF SAMPLES FROM THE HUMAN BODY TO OBTAIN INFORMATION ON PHYSIOLOGICAL AND PATHOLOGICAL STATES. THE PR4100 SYSTEM WAS TURNED OFF AND NO INJURY OCCURRED. BIO-RAD LABORATORIES TECHNICAL SUPPORT SENT THE CUSTOMER A TRIPP LITE USB HUB AS A REPLACEMENT. A FIELD CORRECTIVE ACTION HAS BEEN GENERATED TO REPLACE ALL EXISTING D-LINK HUBS THAT ARE CURRENTLY IN USE FOR PR4100 MICROPLATE READER CUSTOMERS. BIO-RAD LABORATORIES WILL SUBMIT A FOLLOW-UP REPORT UPON COMPLETION OF THE FIELD CORRECTIVE ACTION.

    Description of Event or Problem · 1

    AS NOTED IN OUR INITIAL REPORT BIO-RAD LABORATORIES COMMITTED TO PROVIDING A FOLLOW-UP REPORT TO THE FDA. THERE HAS BEEN NO NEW OR ADDITIONAL INFORMATION, AND BIO-RAD LABORATORIES HAS COMPLETED THE FIELD ACTION FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229360 PR4100 MICROPLATE READER US SPECTROPHOTOMETER FOR CLINICAL USE JJQ BIO-RAD LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1