BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 10355295 · Received August 3, 2020

    Report

    Report Number
    3016438761-2020-00151
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 13, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CALIBRATED THE ARCHITECT SAMPLE PROBE WHICH RESOLVED THE ISSUE. THERE WERE NO ADDITIONAL DISCREPANT RESULTS REPORTED ON THE ARCHITECT, SERIAL NUMBER C1601491, AFTER THE PROBE WAS CALIBRATED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ARCHITECT C1601491 INSTRUMENT SERVICE HISTORY, IDENTIFIED NO CONTRIBUTING FACTORS TO THE DISCREPANT RESULTS, NOR DID IT IDENTIFY ANY ADDITIONAL ERRATIC OR DISCREPANT RESULTS REPORTED. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. A REVIEW OF HISTORICAL DATA FOR THE ARCHITECT PROBE ASSOCIATED WITH THIS COMPLAINT, REVEALED NO TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES. A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS, INCLUDING, BUT NOT LIMITED TO THE TROUBLESHOOTING PERFORMED BY THE CUSTOMER. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT SERIAL NUMBER C1601491, OR THE ARCHITECT PROBE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. PATIENT IDENTIFIER SID'S: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED LDH RESULTS GENERATED ON THE ARCHITECT C16000 ANALYZER ON FOUR PATIENTS. RESULTS PROVIDED: (B)(6) 2020: SID (B)(6)= 368 U/L, ANOTHER ARCHITECT = 231 / 253 U/L. SID (B)(6)= 351 U/L, ANOTHER ARCHITECT = 151 / 147 U/L. SID (B)(6)= 408 U/L, ANOTHER ARCHITECT = 272 / 284 U/L. SID (B)(6)= 461 U/L, ANOTHER ARCHITECT = 224 / 217 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822598 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CC LDH LIST 02P56-22 LOT 18818UN19| CC LDH LIST 02P56-22 LOT 18818UN19