BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAKO COVERSTAINER

    MDR report key: 18624941 · Received February 1, 2024

    Report

    Report Number
    3003423869-2024-00010
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 22, 2024
    Report Date
    June 26, 2024
    Manufacturer
    AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
    Product Code
    KPA
    UDI-DI
    05700571112571
    Removal / Correction Number
    Z-1919-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THAT RECALL NUMBER, Z-1919-2024, HAS BEEN RECEIVED. AGILENT TECHNOLOGIES INITIATED A RECALL APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS; RECALL EVENT ID (B)(4). CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THAT RECALL REFERENCE NUMBER, (B)(4), HAS BEEN RECEIVED. AGILENT TECHNOLOGIES RECALL, REFERENCE NUMBER (B)(4), HAS BEEN INITIATED APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS. CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    AGILENT TECHNOLOGIES HAS INITIATED A RECALL IN APRIL 2024 WITH THE SCOPE OF NOTIFYING ALL COVERSTAINER CUSTOMERS OF THE FOLLOWING ISSUE: THE LOWER DOOR THAT OPENS TO THE REAGENT BOTTLES IS CRACKING AND/OR BREAKING OFF IN THE UPPER CORNER OF THE PLEXIGLASS. CAPA01211 HAS ADDRESSED THE ISSUE AND THE INVESTIGATION HAS BEEN COMPLETED. AGILENT TECHNOLOGIES HAS DETERMINED THE ROOT CAUSE AS SUCH; THE LOWER DOOR SUPPORT BRACKET, WHICH CONNECTS THE HINGES TO THE LOWER DOOR, IS ONLY ATTACHED TO THE PLEXIGLASS AND NOT TO THE METAL FRAME WHICH IS THE MAIN SUPPORT STRUCTURE OF THE LOWER DOOR. THE WEIGHT OF THE PLEXIGLASS DOOR IS IN TURN CRACKING/BREAKING AT THIS JOINT. CUSTOMERS HAVE BEEN NOTIFIED OF THIS ISSUE VIA A CUSTOMER LETTER. AGILENT TECHNOLOGIES WORKED WITH THE MANUFACTURER TO RE-DESIGN THE SUPPORT BRACKET FOR THE LOWER DOOR HINGES, SO THE WEIGHT OF THE LOWER DOOR ASSEMBLY IS NOT SUPPORTED BY THE PLEXIGLASS, BUT BY THE METAL FRAME OF THE LOWER DOOR. THIS NEW BRACKET IS BEING VERIFIED FOR EFFECTIVENESS; ONCE COMPLETED THIS BRACKET WILL BE INSTALLED AT THE CUSTOMER'S NEXT SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    NO ERRONEOUS STAINING RESULT WAS REPORTED BY THE CUSTOMER IN CONNECTION WITH THIS INCIDENT. NO PATIENT OR USER HARM WAS INDICATED. A1-A6: PATIENT INFORMATION HAS NOT BEEN PROVIDED BY THE USER. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THE INSTRUMENT EXPERIENCED A SIMILAR FAILURE MODE RELATED TO REPORTABLE COMPLAINT WITH INJURY, REFERENCE NUMBER MDR: (B)(4), MHRA: (B)(4), AGILENT (B)(6). THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.

    Description of Event or Problem · 0

    THE SOUTH KOREA CUSTOMER REPORTED THE LOWER DOOR OF THE COVERSTAINER IS BROKEN. A PICTURE PROVIDED SHOWS THE TOP RIGHT CORNER OF THE DOOR HAS DETACHED FROM THE REST OF THE DOOR. THE FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT REPLACED THE LOWER DOOR WHICH RESOLVED THIS MALFUNCTION. THIS ISSUE DOESN'T AFFECT THE UTILITY OF THE INSTRUMENT AND SO THE CUSTOMER WAS ABLE TO CONTINUE USING THE INSTRUMENT TO COMPLETE TESTING. THE INSTRUMENT IS FULLY OPERATIONAL, WITHIN SPECIFICATION, AND READY FOR USE. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED. THE INVESTIGATION IS ONGOING, CAPTURED IN CAPA01211, AND A SUPPLEMENTAL WILL BE PROVIDED WHEN NEW PERTINENT INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249102 DAKO COVERSTAINER AUTOMATED SLIDE STAINER KPA AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. CS100 05700571112571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown