BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 12883715 · Received November 29, 2021

    Report

    Report Number
    3016438761-2021-00497
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Date of Event
    November 4, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED EXTENSIVE TROUBLESHOOTING. DURING THIS TROUBLESHOOTING SERVICE DISCOVERED THE TRIGGER AND FLUSH VALVES WERE LEAKING. THE VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-01 AND THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03 WERE REPLACED, WHICH RESOLVED THE ISSUE. A REVIEW OF SERVICE HISTORY FOR THE ARCHITECT I1000SR SERIAL NUMBER (B)(6) REVEALED NO SUBSEQUENT ISSUES HAVE BEEN REPORTED RELATED TO ERRATIC DISCREPANT RESULTS, NOR DID IT IDENTIFY ANY CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING FOR THE REPLACED PARTS DID NOT IDENTIFY ANY TRENDS. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I/ARCHITECT IA DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE INSTRUMENT PART OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-01 OR THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03 OR THE ARCHITECT I1000SR SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    MULTIPLE SIDS ARE INVOLVED; NO PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED. 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 QUESTIONED RESULTS GENERATED WITH THE ARCHITECT I1000SR PROCESSING MODULE, CITING THAT THE RESULTS DID NOT MATCH WITH PATIENT HISTORY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) HBSAGQ2 (B)(6), SID (B)(6) TOXO IGM (B)(6), SID (B)(6) HIV AG/AB (B)(6), SID (B)(6)HBSAGQ2 (B)(6), SID (B)(6)ANTI-HBC II (B)(6), SID (B)(6) TOXO IGG (B)(6), SID (B)(6) ANTI-HBC II (B)(6), SID (B)(6) HBSAGQ2 (B)(6), SID (B)(6) ANTI-HBC II(B)(6), SID (B)(6) HBSAGQ2 (B)(6), SID(B)(6) ANTI-HBC II (B)(6), SID (B)(6) HBSAGQ2 (B)(6), SID (B)(6) HBSAGQ2 (B)(6), SID (B)(6) ANTI-HCVLL(B)(6), SID (B)(6) ANTI-HBCLL (B)(6), SID (B)(6) HBSAGQ2 (B)(6), SID(B)(6) ANTI-HCV II (B)(6), SID (B)(6) ANTI-HBCLL (B)(6), SID (B)(6) ANTI-HBS (B)(6), SID (B)(6) HBSAGQ2 (B)(6), SID (B)(6) ANTI-HCV II (B)(6), SID (B)(6) ANTI-HBCLL (B)(6), SID (B)(6) ANTI-HBS (B)(6), SID (B)(6) HBSAGQ2 (B)(6), SID (B)(6) ANTI-HCV II (B)(6), SID (B)(6) ANTI-HBCLL (B)(6), SID (B)(6)HBSAGQ2 (B)(6), SID (B)(6) ANTI-HBCLL (B)(6), AND SID (B)(6) ANTI-HBS (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780970 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-01 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC ANTI HCV RGT 100 TE, 06C37-28, UNKNOWN| ARC ANTI HCV RGT 100 TE, 06C37-28, UNKNOWN| ARC ANTI-HBC II, 08L44-25, UNKNOWN| ARC ANTI-HBC II, 08L44-25, UNKNOWN| ARC ANTI-HBS RGT 100T R, 07C18-29, UNKNOWN| ARC ANTI-HBS RGT 100T R, 07C18-29, UNKNOWN| ARC HBSAG QUAL II (100T, 02G22-25, UNKNOWN| ARC HBSAG QUAL II (100T, 02G22-25, UNKNOWN| ARC HIV AG/AB RGT, 04J27-27, UNKNOWN| ARC HIV AG/AB RGT, 04J27-27, UNKNOWN| ARC TOXO-G RGT, 06C19-25, UNKNOWN| ARC TOXO-G RGT, 06C19-25, UNKNOWN| ARC TOXO-M 100T, 06C20-25, UNKNOWN| ARC TOXO-M 100T, 06C20-25, UNKNOWN