BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 PROCESSING MODULE

    MDR report key: 23986171 · Received January 6, 2026

    Report

    Report Number
    3016438761-2026-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 28, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A1 - 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.

    Additional Manufacturer Narrative · 0

    CONCOMITANT INFORMATION WAS UPDATED FOR LOT# 75412UD00 FROM 03P68-21 TO 03P68-34. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ARCHITECT C16000 PROCESSING MODULE, SERIAL NUMBER (B)(6) AND FOUND A BLOCKAGE IN THE WASTE LINE AN HCW PUMP OUT TO T FTG (ROHS) TUBING AND CLEARED THE CLOG. REMOVAL OF THE CLOG FROM THE HCW PUMP OUT TO T FTG (ROHS) RESOLVED THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC MAGNESIUM. THERE WERE NO ADDITIONAL 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 DID NOT IDENTIFY ANY TRENDS FOR THE ARCHITECT C16000 PROCESSING MODULE WITH REGARDS TO THE CUSTOMER REPORTED EVENT. A REVIEW OF TRENDING DATA ASSOCIATED WITH THE HCW PUMP OUT TO T FTG (ROHS) DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 PROCESSING MODULE, SERIAL NUMBER (B)(6) OR THE HCW PUMP OUT TO T FTG (ROHS) WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON A 89 YEARS OLD MALE PATIENT ON THE ARCHITECT C16000. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2025, SID (B)(6), INITIAL RESULT =3.35 MMOL/L, REPEAT RESULT FROM ANOTHER INSTRUMENT 0.94 MMOL/L. THE CUSTOMER USES REFERENCE RANGE 1.60 ¿ 2.60 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON (B)(6) MALE PATIENT ON THE ARCHITECT C16000. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2025, SID (B)(6), INITIAL RESULT =3.35 MMOL/L, REPEAT RESULT FROM ANOTHER INSTRUMENT 0.94 MMOL/L. THE CUSTOMER USES REFERENCE RANGE 1.60 ¿ 2.60 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46951 ARCHITECT C16000 PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male CC MAGNESIUM (3750T), 03P68-34, 75412UD00| CC MAGNESIUM 1000T, 03P68-21, 75412UD00| TUBING, PERISTALTIC HEAD (ROHS), 7-35009685-04, UN| TUBING, PERISTALTIC HEAD (ROHS), 7-35009685-04, UN