BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 5241249 · Received November 20, 2015

    Report

    Report Number
    3022521-2015-00012
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    September 9, 2015
    Report Date
    January 18, 2016
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    K092353
    Removal / Correction Number
    3022521- 12/22/15/15-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIO-RAD WILL PROCEED WITH A FIELD CORRECTION TO ADD AN ADDITIONAL WARNING LABEL DIRECTLY TO THE INSTRUMENT DRAWER, CAUTIONING USERS TO ENSURE THAT THE PLATE HAS STOPPED MOVING BEFORE OPENING THE DRAWER AND THAT DURING ERROR CODES, THE DRAWER MAY UNLOCK WITHOUT THE LED INDICATOR ILLUMINATING.

    Additional Manufacturer Narrative · 1

    ON 11/20/2015, A MDR WAS FILED FOR THIS EVENT (3022521-2015-00012). ON 1/7/2016, A FOLLOW-UP MDR WAS FILED FOR THIS EVENT (3022521-2016-00001). THIS SECOND FOLLOW-UP IS TO CORRECT THE CATALOG NUMBER OF THE PRODUCT. THE CORRECT CATALOG NUMBER IS 89601.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE CUSTOMER CONTACTED BIO-RAD LABORATORIES TECHNICAL SERVICES TO REPORT AN ISSUE THAT OCCURS WITH THE INSTRUMENT DURING AN ERROR CODE INDICATING A LOW LEVEL OF CLEAN FLUID. THE TECHNICIAN NOTED THAT THEY CAN HEAR THE BOTTOM DRAWER LOCK CLICK OPEN WHEN THE INSTRUMENT PAUSES IN ERROR MODE. THE CUSTOMER WAS CONCERNED THAT FOR A VERY SHORT TIME AFTER THE DRAWER UNLOCKS, THE DRAWER CAN BE OPENED WHILE THE PLATE TRANSPORT IS STILL MOVING AND THE SAMPLE WELL PLATE CAN BE PUSHED OFF THE PLATFORM. NOTE: THE OPERATOR'S MANUAL, IN CHAPTER 4.9.2, HAS A SAFETY WARNING CAUTIONING USERS TO ENSURE THAT THE PLATE TRANSPORT HAS STOPPED MOVING BEFORE OPENING THE BOTTOM DRAWER. THEREFORE, THE CUSTOMER'S OBSERVATION IS CONSIDERED NORMAL OPERATION BY THE INSTRUMENT THAT IS MITIGATED VIA WARNINGS IN THE LABELING AND IS NOT CONSIDERED TO BE A MALFUNCTION. ON (B)(6) 2015, A FIELD SERVICE ENGINEER (FSE) VERIFIED THE CUSTOMER CONCERN AT THE CUSTOMER'S LABORATORY. THE FSE STOPPED AN ASSAY WHEN THE PLATE TRANSPORT WAS BETWEEN TWO LOCATIONS AND WAS ABLE TO OPEN THE INSTRUMENT DRAWER WHILE THE PLATE TRANSPORT CONTINUED ON TO ITS LAST LOCATION OF THE COMMAND. EXAMINATION OF THE ISSUE WAS DISCUSSED AND INVESTIGATION OF THE ISSUE CONTINUED AT BIO-RAD LABORATORIES SEATTLE OPERATIONS. IN THIS INSTANCE, NO MALFUNCTION WAS OBSERVED, AS THE LED WAS ILLUMINATION WAS SYNCHRONIZED WITH THE DRAWER UNLOCKING. ON (B)(6) 2015, TESTING WAS PERFORMED TO TRY TO REPLICATE THE CUSTOMER'S FINDING AT BIO-RAD LABORATORIES SEATTLE OPERATIONS. THE SAME ISSUE WAS OBSERVED DURING TESTING OF THE INSTRUMENT UNDER ERROR CODE. THE ADDITIONAL FINDING NOTED WAS THAT THE DOOR UNLOCKS WITHOUT THE LED LIGHT ILLUMINATING TO INDICATE THAT THE DOOR HAS BEEN UNLOCKED. THE LACK OF SYNCHRONIZATION BETWEEN THE DRAWER UNLOCKING AND THE LED INDICATOR IS BEING CONSIDERED AS AN INSTRUMENT MALFUNCTION. SINCE THE LED INDICATOR FOR THE DRAWER LOCK IS CONSIDERED TO BE A SAFETY FEATURE OF THE INSTRUMENT, THE OBSERVED MALFUNCTION IN THE SYNCHRONIZATION OF THE LED INDICATOR AND THE DRAWER LOCK (ONLY WHEN THE INSTRUMENT IS PAUSED DUE TO AN ERROR CODE) IS BEING CONSIDERED TO BE SUBJECT TO MDR REPORTING REQUIREMENTS.

    Description of Event or Problem · 1

    ON 11/20/2015, A MDR WAS FILED FOR THIS EVENT (3022521-2015-00012). ON 1/7/2016, A FOLLOW-UP MDR WAS FILED FOR THIS EVENT (3022521-2016-00001). THIS SECOND FOLLOW-UP IS TO CORRECT THE CATALOG NUMBER OF THE PRODUCT. THE CORRECT CATALOG NUMBER IS 89601.

    Description of Event or Problem · 1

    (THIS FOLLOW-UP SUBMISSION WAS ORIGINALLY FILED ON 1/07/2016). ON (B)(6) 2015, THE CUSTOMER CONTACTED BIO-RAD LABORATORIES TECHNICAL SERVICES TO REPORT AN ISSUE THAT OCCURS WITH THE INSTRUMENT DURING AN ERROR CODE INDICATING A LOW LEVEL OF CLEAN FLUID. THE TECHNICIAN NOTED THAT THEY CAN HEAR THE BOTTOM DRAWER LOCK CLICK OPEN WHEN THE INSTRUMENT PAUSES IN ERROR MODE. THE CUSTOMER WAS CONCERNED THAT FOR A VERY SHORT TIME AFTER THE DRAWER UNLOCKS, THE DRAWER CAN BE OPENED WHILE THE PLATE TRANSPORT IS STILL MOVING AND THE SAMPLE WELL PLATE CAN BE PUSHED OFF THE PLATFORM. NOTE: THE OPERATOR'S MANUAL, IN CHAPTER 4.9.2, HAS A SAFETY WARNING CAUTIONING USERS TO ENSURE THAT THE PLATE TRANSPORT HAS STOPPED MOVING BEFORE OPENING THE BOTTOM DRAWER. THEREFORE, THE CUSTOMER'S OBSERVATION IS CONSIDERED NORMAL OPERATION BY THE INSTRUMENT THAT IS MITIGATED VIA WARNINGS IN THE LABELING AND IS NOT CONSIDERED TO BE A MALFUNCTION. ON 9/10/2015, A FIELD SERVICE ENGINEER (FSE) VERIFIED THE CUSTOMER CONCERN AT THE CUSTOMER'S LABORATORY. THE FSE STOPPED AN ASSAY WHEN THE PLATE TRANSPORT WAS BETWEEN TWO LOCATIONS AND WAS ABLE TO OPEN THE INSTRUMENT DRAWER WHILE THE PLATE TRANSPORT CONTINUED ON TO ITS LAST LOCATION OF THE COMMAND. EXAMINATION OF THE ISSUE WAS DISCUSSED AND INVESTIGATION OF THE ISSUE CONTINUED AT BIO-RAD LABORATORIES SEATTLE OPERATIONS. IN THIS INSTANCE, NO MALFUNCTION WAS OBSERVED, AS THE LED WAS ILLUMINATION WAS SYNCHRONIZED WITH THE DRAWER UNLOCKING. ON 10/26/2015, TESTING WAS PERFORMED TO TRY TO REPLICATE THE CUSTOMER'S FINDING AT BIO-RAD LABORATORIES SEATTLE OPERATIONS. THE SAME ISSUE WAS OBSERVED DURING TESTING OF THE INSTRUMENT UNDER ERROR CODE. THE ADDITIONAL FINDING THAT WAS NOTED WAS THAT THE DOOR APPEARED TO UNLOCK WITHOUT THE LED LIGHT ILLUMINATING TO INDICATE THAT THE DOOR HAS BEEN UNLOCKED. THE APPARENT LACK OF SYNCHRONIZATION BETWEEN THE DRAWER UNLOCKING AND THE LED INDICATOR WAS CONSIDERED AS AN INSTRUMENT MALFUNCTION. SINCE THE LED INDICATOR FOR THE DRAWER LOCK IS CONSIDERED TO BE A SAFETY FEATURE OF THE INSTRUMENT, THE OBSERVED APPARENT MALFUNCTION IN THE SYNCHRONIZATION OF THE LED INDICATOR AND THE DRAWER LOCK (ONLY WHEN THE INSTRUMENT IS PAUSED DUE TO AN ERROR CODE) WAS CONSIDERED TO BE SUBJECT TO MDR REPORTING REQUIREMENTS. ON 11/20/2015, A MDR WAS FILED FOR THIS EVENT (3022521-2015-00012). ON12/4/2015, BIO-RAD PRODUCT SUPPORT TESTED SCENARIOS OF THIS ISSUE AND FOUND THAT IN FACT, THERE WAS NO MALFUNCTION, AS THE PRODUCT TESTING TEAM HAD OBSERVED THE WRONG INDICATOR. IN FACT, AN ADDITIONAL LED ASSOCIATED WITH THE LOWER DRAWER WAS FUNCTIONING CORRECTLY. THEREFORE, THIS INCIDENT DID NOT INVOLVE AN INSTRUMENT MALFUNCTION. HOWEVER, THE USER REPORTING THIS INCIDENT INDICATED THEY WERE NOT AWARE OF THE WARNING IN THE OPERATION MANUAL REGARDING MOVING PARTS. THEREFORE, THIS INCIDENT IS BEING CONSIDERED AS REMAINING SUBJECT TO MDR REPORTING REQUIREMENTS SINCE THE WARNING WAS NOT PROMINENT ENOUGH TO PREVENT THE USER FROM OPENING THE DRAWER WHILE PARTS WERE STILL MOVING. BIO-RAD IS CONDUCTING A FIELD ACTION TO APPLY AN ADDITIONAL WARNING LABEL ON THE INSTRUMENT ITSELF IN ORDER TO ENHANCE VISIBILITY OF THIS WARNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771492 EVOLIS MICROPLATE SYSTEM 4 PS SYSTEM JJE BIO-RAD LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1