BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 16616812 · Received March 26, 2023

    Report

    Report Number
    3016438761-2023-00158
    Event Type
    Malfunction
    Date Received
    March 26, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 19, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003746
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT TESTING ADDED TO SECTION B5: DESCRIBE EVENT OR PROBLEM.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING DISCREPANT SODIUM RESULTS ON THE ARCHITECT C4000, SERIAL # (B)(6). SERVICE PERFORMED EXTENSIVE TROUBLESHOOTING AND REPLACED SEVERAL PARTS INCLUDING THE MIXER (09D59-04 LOT # SZ47068275). THE MIXER (09D59-04 LOT # SZ47068275) WAS DETERMINED TO BE THE LIKELY CAUSE OF THE FALSELY ELEVATED RESULT. PART REPLACEMENT RESOLVED THE ISSUE. NO ADDITIONAL DISCREPANT SODIUM RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED A INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6). THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C4000 PROCESSING MODULE, MIXER (09D59-04 LOT # SZ47068275) DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C4000 PROCESSING MODULE, MIXER (09D59-04 LOT # SZ47068275), WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE. THE ORIGINAL SAMPLES WERE REPEATED AND THE RESULTS WERE NORMAL. THE FOLLOWING DATA WAS PROVIDED: PROCESSED ON 06MAR2023 SODIUM INITIAL RESULT = 166 REPEAT RESULT = 143. PROCESSED ON 08MAR2023 SODIUM INITIAL RESULT = 166 REPEAT RESULT = 143. PROCESSED ON 07MAR2023 SODIUM INITIAL RESULT = 164 REPEAT RESULT = 139. NORMAL LAB VALUES= SODIUM = 136 TO 145 MEQ/L ADDITIONAL DATA PROVIDED 29MAR2023 SID (B)(6) PROCESSED 28MAR2023 INITIAL RESULT 169 REPEAT 143/163/143 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE. THE ORIGINAL SAMPLES WERE REPEATED AND THE RESULTS WERE NORMAL. THE FOLLOWING DATA WAS PROVIDED: PROCESSED ON (B)(6) 2023 SODIUM INITIAL RESULT = 166 REPEAT RESULT = 143. PROCESSED ON (B)(6) 2023, SODIUM INITIAL RESULT = 166, REPEAT RESULT = 143. PROCESSED ON (B)(6) 2023 SODIUM INITIAL RESULT = 164 REPEAT RESULT = 139. NORMAL LAB VALUES= SODIUM = 136 TO 145 MEQ/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472740 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-01 00380740003746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BD, ICT PREAMP (ROHS), 2-89032-04, SZ21011936| BD, ICT PREAMP (ROHS), 2-89032-04, SZ21011936| BD, ICT PREAMP (ROHS), 2-89032-04, SZ21011936| MIXER, 09D59-04, SZ47068275