BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 12756571 · Received November 7, 2021

    Report

    Report Number
    3016438761-2021-00417
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 10, 2021
    Report Date
    December 3, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE INSPECTED THE ANALYZER AND REPLACED THE SAMPLE PROBE, C16 RGT PR(L)ROHS, C16 RGT PR(R)ROHS, AND THE ARC C8K SMP PR TB WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. AN 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 FOR THE SAMPLE PROBE, C16 RGT PR(L)ROHS, C16 RGT PR(R)ROHS, AND THE ARC C8K SMP PR TB DID NOT IDENTIFY ANY TRENDS. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT C16000 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 FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 PROCESSING MODULE FOR SERIAL (B)(6) OR THE SAMPLE PROBE, C16 RGT PR(L)ROHS, C16 RGT PR(R)ROHS, AND THE ARC C8K SMP PR TB 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 A FALSELY DEPRESSED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR A NEWBORN BABY WITH JAUNDICE COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE IS <100 UMOL/L): A SAMPLE WAS TESTED ON THE WARD WITH A BLOOD GAS INSTRUMENT THAT GENERATED A RESULT OF > 100 UMOL/L. SAMPLES WERE THEN SENT TO THE LABORATORY AND TESTED ON THE ARCHITECT: (B)(6) 2021 SID (B)(6) INITIAL RESULT = 72 UMOL/L; (B)(6) 2021 SID (B)(6) INITIAL RESULT = 150 UMOL/L, THE SAMPLE WAS SLIGHTLY HEMOLYZED WITH A HEMOLYSIS INDEX OF 1.52 THE SAMPLES WERE REPEATED AND GENERATED REPRODUCIBLE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR A NEWBORN BABY WITH JAUNDICE COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE IS <100 UMOL/L): A SAMPLE WAS TESTED ON THE WARD WITH A BLOOD GAS INSTRUMENT THAT GENERATED A RESULT OF > 100 UMOL/L. SAMPLES WERE THEN SENT TO THE LABORATORY AND TESTED ON THE ARCHITECT: (B)(6) 2021 (B)(6) INITIAL RESULT = 72 UMOL/L (B)(6) 2021 (B)(6) INITIAL RESULT = 150 UMOL/L, THE SAMPLE WAS SLIGHTLY HEMOLYZED WITH A HEMOLYSIS INDEX OF 1.52 THE SAMPLES WERE REPEATED AND GENERATED REPRODUCIBLE RESULTS. PER Q-22-01-015, EDITION 004, FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS WITH A SHIFT >22% IS REPORTABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658820 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CC TOTAL BILI, 06L45-80, UNKNOWN| CC TOTAL BILI, 06L45-80, UNKNOWN