BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 PROCESSING MODULE

    MDR report key: 23179994 · Received September 30, 2025

    Report

    Report Number
    3016438761-2025-00569
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 6, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND DETERMINED A CLOG IN THE TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01). THE PART WAS REPLACED, AND THE ISSUE WAS RESOLVED. A REVIEW OF THE ARCHITECT C16000 PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL ERRATIC RESULTS PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. A REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01) DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS. THE ARCHITECT C16000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTIONS FOR THE REMOVAL, REPLACEMENT AND VERIFICATION OF THE PERISTALTIC HEAD TUBING (ROHS) (7-202464-01). A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT C16000 PROCESSING MODULE, SERIAL NUMBER C1601140, OR THE TUBING, PERISTALTIC HEAD (ROHS).

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 MAGNESIUM RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR A PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6) INITIAL=2.69 MMOL/L /REPEATED=0.78 MMOL/L LABORATORY REFERENCE RANGE FOR MAGNESIUM=0.70 TO 1.00 MMOL/L ; CRITICAL RANGE=< 0.50 AND >2.00 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR A PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2025, SID (B)(6), INITIAL=2.69 MMOL/L /REPEATED=0.78 MMOL/L. LABORATORY REFERENCE RANGE FOR MAGNESIUM=0.70 TO 1.00 MMOL/L; CRITICAL RANGE=< 0.50 AND >2.00 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106093 ARCHITECT C16000 PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CC MAGNESIUM (3750T), 03P68-34, 73187UD00| CC MAGNESIUM (3750T), 03P68-34, 73187UD00