BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS 6800 SYSTEM

    MDR report key: 10474265 · Received August 31, 2020

    Report

    Report Number
    2243471-2020-00016
    Event Type
    Injury
    Date Received
    August 31, 2020
    Date of Event
    August 5, 2020
    Report Date
    October 22, 2020
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MZA
    PMA / PMN Number
    BK140196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INDICATES THE FSES¿ INJURIES WERE MOST LIKELY CAUSED BY THE COBAS LYSIS REAGENT. THE INSTRUMENT USES SEVERAL REAGENTS TO PROCESS A SAMPLE, THE ONLY REAGENT WITH SAFETY SYMBOLS AND WARNINGS IS COBAS LYSIS REAGENT (LYS). THE INVESTIGATION ON THE INSTRUMENT LABELING, REAGENT LABELING AND SERVICE DOCUMENTATION SHOWED THEY ARE RAISING PROPER AWARENESS OF POTENTIAL RISKS WHEN USING THE INSTRUMENT OR REAGENTS. SPECIFICALLY, LABELLING FOR THE LYSIS REAGENT CONTAINS THE STATEMENT: P303 + P361 + P353: IF ON SKIN (OR HAIR): TAKE OFF IMMEDIATELY ALL CONTAMINATED CLOTHING. RINSE SKIN WITH WATER. THE COBAS 6800/8800 SYSTEMS COBAS P 680 INSTRUMENT SAFETY GUIDE ALSO CONTAINS A PRECAUTIONARY SECTION ABOUT SKIN INFLAMMATION OR INJURY WITH REAGENTS AND OTHER WORKING SOLUTIONS. THE SERVICE INSTRUCTIONS USED BY FSES, CONTAINS ADDITIONAL GENERAL SAFETY AND PRECAUTIONARY INFORMATION WHEN DOING REPAIR AND MAINTENANCE ACTIVITIES. THE OPERATOR/FSE IS RESPONSIBLE OF PROPER UNDERSTANDING AND IMPLEMENTATION OF THE SAFETY GUIDANCE. INVESTIGATION ALSO FOUND THE LYS CRYSTALLIZATION INSIDE THE INSTRUMENT BUILDUP WAS DETECTED AT CONNECTOR S26, THIS LED TO A BUILDUP OF CRYSTALLIZATION ABOVE THE CONNECTOR. THE FSE CONFIRMED THE WASH TOWER WAS PROPERLY INSERTED AND NOT CRACKED, BUT THE O-RINGS WERE MISSING. THE O-RINGS WERE NOT INSTALLED DURING THE ASSEMBLY OF THE INSTRUMENT. A CAPA HAS BEEN INITIATED. TO INCREASE THE VISIBILITY OF THE O-RING, TO ENSURE PROPER INSTALLATION OF THE O-RING WITHIN THE CONNECTION TUBE, A CHANGE OF THE MATERIAL FOR THE CONNECTION TUBE IS ONGOING AND SHOULD THEREFORE RESOLVE THE ISSUE OF VISIBILITY OF THE O-RINGS DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE SECOND FSE INJURED IN THE REPORTED CASE IS REPORTED IN A SEPARATE MDR. (B)(4).

    Description of Event or Problem · 1

    TWO ROCHE FIELD SERVICE ENGINEERS (FSES) WENT TO A CUSTOMER SITE TO PERFORM SERVICE ACTIVITIES ON A COBAS 6800 INSTRUMENT. THE FSES OBSERVED A HIGH AMOUNT OF CRYSTALLIZATION INSIDE THE INSTRUMENT. WHEN WORKING ON THE INSTRUMENT FOR AN UNRELATED ISSUE, THE FSES LIKELY GOT IN CONTACT WITH THE CRYSTALLIZED MATERIALS PRESENT WITHIN THE INSTRUMENT, WHICH SUBSEQUENTLY CAUSED BURNS ON THEIR SKIN. BOTH FSES WENT TO THE EMERGENCY ROOM. THIS MDR IS FOR ONE OF FSE WHO SUFFERED A FIRST-DEGREE BURN ON HIS LEFT FOREARM. THE DOCTOR RINSED HIS SKIN WITH A BASE SOLUTION AND PUT OINTMENT ON IT. NO FOLLOW UP VISIT WAS NEEDED. IT WAS INDICATED THAT THE FSES WERE WEARING LAB COATS WHEN THE EVENT OCCURRED. A SEPARATE MDR IS FILED FOR THE SECOND FSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939300 COBAS 6800 SYSTEM TEST, EQUIPMENT, AUTOMATED BLOODBORNE PATHOGEN MZA ROCHE MOLECULAR SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention