BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 11415447 · Received March 4, 2021

    Report

    Report Number
    3016438761-2021-00075
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 12, 2021
    Report Date
    June 15, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. PATIENT INFORMATION: PATIENT IDENTIFIER: PATIENT (B)(6) (PREGNANT FEMALE); PATIENT (B)(6). NO OTHER PATIENT INFORMATION AVAILABLE. SERVICE INSPECTED THE ANALYZER AND FOUND THE SAMPLE SYRINGE MOTOR CORRODED. SERVICE DETERMINED THE SYRINGE ASSY (7-77650-07) AND VALVE, MANIFOLD KIT (ROHS) (7-77612-03) THE LIKELY CAUSES OF THE ISSUE AND REPLACED THE PARTS. PART REPLACEMENT RESOLVED THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW DETERMINED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(4) WAS IDENTIFIED. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. TRENDING REVIEW DETERMINED NO TRENDS WERE IDENTIFIED FOR SYRINGE ASSY (7-77650-07) OR THE VALVE, MANIFOLD KIT (ROHS) (7-77612-03). THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE ARCHITECT I2000SR (B)(4) RELATED TO THE ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I2000SR ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) ARCHITECT (B)(6) QUALITATIVE AND ARCHITECT (B)(6) RESULTS FOR 2 PATIENTS WHEN RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) RESULTS (REFERENCE RANGE:(B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314448 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC HAVAB-G, 06L27-25, (B)(4)| ARC HAVAB-G, 06L27-25, (B)(4)| ARC HBSAG 2 RGT, 04P53-35, (B)(4)| ARC HBSAG 2 RGT, 04P53-35, (B)(4)