BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 16713734 · Received April 11, 2023

    Report

    Report Number
    3016438761-2023-00194
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 23, 2023
    Report Date
    April 28, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE REPRESENTATIVE (FSR) WAS SPRAYED IN THE FACE WITH WASTE LIQUID WHEN SERVICING THE ARCHITECT C16000, SERIAL # (B)(6) AND THE TBG, EXTERNAL HC WASTE (ROHS) AND TBG. H.C. NOZZLE A WASTE (ROHS) DISLODGED SPRAYING THE FSR. THE TBG, EXTERNAL HC WASTE (ROHS)_PART NUMBER 7-203164-01 AND TBG. H.C. NOZZLE A WASTE (ROHS)_PART NUMBER 7-203008 WERE DEEMED THE LIKELY CAUSE FOR THE FACE SPLASH. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH THE ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. A REVIEW OF THE SCORECARD IDENTIFIED NO SIMILAR ISSUES RELATED TO THE ARCHITECT C16000 OR LIKELY CAUSE PARTS AS DESCRIBED. A REVIEW OF HISTORICAL DATA FOUND NO NON-CONFORMANCES RELATED TO THE CURRENT COMPLAINT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY FOR THE ARCHITECT C16000 PROCESSING MODULE SN (B)(6) WAS IDENTIFIED. CORRECTED INFORMATION IN H6 - HEALTH EFFECT CLINICAL CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SILTED EXTERNAL HIGH-CONCENTRATION WASTE TUBING OF THE ARCHITECT C16000 PROCESSING MODULE CAUSED THE SUDDEN LOOSENING OF THE HIGH-CONCENTRATION WASTE TUBING A CAUSING WASTE TO BE SPRAYED IN THE FACE OF THE FIELD SERVICE REPRESENTATIVE. NO INTERVENTION WAS REQUIRED BESIDES WASHING WITH SOAP AND WATER. THE PERSONAL PROTECTION EQUIPMENT THAT WAS WORN WAS A LAB COAT, NITRILE GLOVES, AND A SURGICAL MASK. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SILTED EXTERNAL HIGH-CONCENTRATION WASTE TUBING OF THE ARCHITECT C16000 PROCESSING MODULE CAUSED THE SUDDEN LOOSENING OF THE HIGH-CONCENTRATION WASTE TUBING A CAUSING WASTE TO BE SPRAYED IN THE FACE OF THE FIELD SERVICE REPRESENTATIVE. NO INTERVENTION WAS REQUIRED BESIDES WASHING WITH SOAP AND WATER. THE PERSONAL PROTECTION EQUIPMENT THAT WAS WORN WAS A LAB COAT, NITRILE GLOVES, AND A SURGICAL MASK. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379981 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Male TBG, EXTERNAL HC WASTE (ROHS), 7-203164-01, UNKNOWN| TBG, EXTERNAL HC WASTE (ROHS), 7-203164-01, UNKNOWN