BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 11628978 · Received April 7, 2021

    Report

    Report Number
    3016438761-2021-00128
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    February 15, 2021
    Report Date
    May 25, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 IDENTIFIER = (B)(6). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED BY THE CUSTOMER DUE TO PRIVACY ISSUES. DURING THE REQUEST SITE VISIT, THE FIELD SERVICE REPRESENTATIVE INSPECTED THE INSTRUMENT AND REPLACED THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03, WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS. THE ARCHITECT I SYSTEMS SERVICE AND SUPPORT MANUAL PROVIDES REMOVAL AND REPLACEMENT PROCEDURES FOR THE VALVE, MANIFOLD KIT (ROHS). A 12-MONTH REVIEW OF TICKETS DID NOT IDENTIFY ANY TRENDS FOR THE VALVE, MANIFOLD KIT (ROHS). A REVIEW OF THE ARCHITECT I1000SR, SERIAL NUMBER (B)(4), SERVICE HISTORY FOUND NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED. 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 HISTORICAL DATA FOR THE PART ASSOCIATED WITH THIS COMPLAINT REVEALED NO TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES ASSOCIATED WITH THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I1000SR, SERIAL NUMBER (B)(4), OR THE VALVE, MANIFOLD KIT (ROHS) PN 7-77612-03 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INCREASE IN (B)(6) ARCHITECT ANTI-HCV RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL = (B)(6) / RETEST = 1(B)(6) / PCR = NEGATIVE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524324 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-01 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC ANTI HCV RGT 100 TE, 06C37-27, 19512BE00| ARC ANTI HCV RGT 100 TE, 06C37-27, 19512BE00