BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 6549069 · Received May 5, 2017

    Report

    Report Number
    3022521-2017-00001
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    April 6, 2017
    Report Date
    June 9, 2017
    Manufacturer
    BIO-RAD LABORATORIES
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED, "ALL EVOLIS INSTRUMENTS (NEW INSTRUMENTS AND EXISTING INSTRUMENTS AT CUSTOMER SITES) CONTAIN THE POTENTIAL HAND INJURY AND BIOHAZARD WARNINGS ON THEM." THE MANUFACTURER HAS REVIEWED THE CUSTOMER COMPLAINTS AND NO INJURY INCIDENTS HAVE OCCURRED SINCE THE HAND INJURY WARNING APPLICATION ON THE INSTRUMENT IN (B)(6)2011. THE MANUFACTURER HAS EVALUATED THE CURRENT LABELING AND DEEMED THAT NO LABELING DEFICIENCY IS CURRENTLY PRESENT. NO SAFETY ACTION BY THE MANUFACTURER WILL BE TAKEN AT THIS TIME DUE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    AS STATED IN DESCRIBE EVENT OR PROBLEM, "ALL EVOLIS INSTRUMENTS (NEW INSTRUMENTS AND EXISTING INSTRUMENTS AT CUSTOMER SITES) CONTAIN THE POTENTIAL HAND INJURY AND BIOHAZARD WARNINGS ON THEM." THE MANUFACTURER HAS REVIEWED THE CUSTOMER COMPLAINTS AND NO INJURY INCIDENTS HAVE OCCURRED SINCE THE HAND INJURY WARNING APPLICATION ON THE INSTRUMENT IN APRIL 2011. THE MANUFACTURER HAS EVALUATED THE CURRENT LABELING AND DEEMED THAT NO LABELING DEFICIENCY IS CURRENTLY PRESENT. NO SAFETY ACTION BY THE MANUFACTURER WILL BE TAKEN AT THIS TIME DUE TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6)2017, BIO-RAD SUBMITTED 3022521-2017-00001 REGARDING A CUSTOMER INJURING THEMSELVES WHILE PERFORMING EVOLIS MANIFOLD MAINTENANCE. ADDITIONAL INFORMATION RECEIVED ON 5/10/2017: ON THE DAY OF THE INJURY/EVENT, THE ONLY TESTING THAT OCCURRED WAS FOR PROFICIENCY TESTING. IN THE PROFICIENCY TESTING, (B)(6) SAMPLES WERE ASSAYED USING THE EVOLIS. THE TECHNICIAN WAS TESTED LAST WEEK AND THE NEXT SCREEN WILL BE IN ONE MONTH. THE TECHNICIAN IS NOT AWARE OF THE REMAINDER OF THE TESTING SCHEDULE. THE INFORMATION ABOVE WAS ALSO SENT TO THE FDA CDRH CONSUMER SAFETY OFFICE ON 5/11/2017.

    Description of Event or Problem · 1

    ON (B)(6) 2017, BIO-RAD RECEIVED A CUSTOMER CALL REGARDING AN INJURY DURING EVOLIS MANIFOLD MAINTENANCE. THE TECHNICIAN WAS STYLETTING THE MANIFOLD WHILE THE MANIFOLD WAS STILL ATTACHED TO THE WASHER ARM. THE WASHER ARM SLIPPED OUT OF THE TECHNICIAN'S HAND AND PUNCTURED THE BACK OF THEIR HAND. THE TECHNICIAN SOUGHT MEDICAL ATTENTION AND IS BEING SCREENED FOR EXPOSURE TO INFECTIOUS AGENTS. THE PATIENT IS CURRENTLY TAKING ANTI-RETROVIRAL MEDICATION AND THE BASELINE INFECTIOUS DISEASE SCREENING WAS NEGATIVE. THIS CUSTOMER SITE RUNS THE FOLLOWING ASSAY TYPES ON THE EVOLIS: (B)(6). THE INSTRUMENT MANIFOLD CONTAINS A POTENTIAL HAND INJURY AND BIOHAZARD WARNING STICKER ON IT INDICATING TO THE USER OF THE POTENTIAL INJURY. ALL EVOLIS INSTRUMENTS (NEW INSTRUMENTS AND EXISTING INSTRUMENTS AT CUSTOMER SITES) CONTAIN THE POTENTIAL HAND INJURY AND BIOHAZARD WARNINGS ON THEM. THE EVOLIS OPERATOR'S MANUAL ALSO CONTAINS A POTENTIAL HAND INJURY WARNING IN THE DOCUMENT MARGIN WHERE THE WASHER MANIFOLD MAINTENANCE IS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330674 EVOLIS MICROPLATE SYSTEM 4 PS SYSTEM JJE BIO-RAD LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other