BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 21095174 · Received January 7, 2025

    Report

    Report Number
    3016438761-2025-00014
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 30, 2024
    Report Date
    February 6, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE ARCHITECT I2000SR FOR SERIAL (B)(6) WAS EVALUATED AND CRYSTALS WERE FOUND ON TWO SYRINGE ASSEMBLIES. THE SYRINGE ASSEMBLIES WERE REPLACED, WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. NO ADDITIONAL DISCREPANT RESULTS WERE REPORTED AFTER THE SERVICE ACTIVITY WAS COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) IDENTIFIED 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 FOR THE ARCHITECT I2000SR DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING FOR THE SYRINGE ASSEMBLY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I2000SR FOR SERIAL (B)(6) OR THE SYRINGE ASSEMBLY WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY POSITIVE ARCHITECT TOTAL B-HCG GENERATED FROM ARCHITECT I2000SR AND PROVIDED THE FOLLOWING DATA: FIRST TEST RESULT OF A HCG SAMPLE WAS 106.3 (POSITIVE). THE RETEST RESULT WAS LESS THAN 1.2 (NEGATIVE). THE CUSTOMER REPORTED OUT THE LESS THAN 1.2 RESULT. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY POSITIVE ARCHITECT TOTAL B-HCG GENERATED FROM ARCHITECT I2000SR AND PROVIDED THE FOLLOWING DATA: FIRST TEST RESULT OF A HCG SAMPLE WAS 106.3 (POSITIVE). THE RETEST RESULT WAS LESS THAN 1.2 (NEGATIVE). THE CUSTOMER REPORTED OUT THE LESS THAN 1.2 RESULT. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321327 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC BHCG 2000T (CN), 07K78-77,| ARC BHCG 2000T (CN), 07K78-77,