BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 8681297 · Received June 9, 2019

    Report

    Report Number
    1628664-2019-00430
    Event Type
    Malfunction
    Date Received
    June 9, 2019
    Date of Event
    May 23, 2019
    Report Date
    September 22, 2021
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE INADVERTENTLY WAS SUBMITTED ON MDR NUMBER 1628664-2019-00430-00 AND IS BEING SUBMITTED UNDER MANUFACTURER REPORT NUMBER 3016438761-2021-00337-00 FOR CORRECTION.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT TROPONIN RESULTS ON THE ARCHITECT I1000SR ANALYZER. THE CUSTOMER PROVIDED FOLLOWING RESULTS, THE REPEAT RESULTS WERE OBTAINED AFTER INSTRUMENT SERVICE: SID (B)(6) INITIAL <0.0, REPEAT 0.27 UG/L, SID (B)(6) INITIAL <0.0, REPEAT 0.38 UG/L , SID (B)(6) INITIAL <0.0, REPEAT 0.09 UG/L, SID (B)(6) INITIAL <0.0, REPEAT 0.07 UG/L, THE CUSTOMER CUTOFF IS 0.15 UG/L. NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474738 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 1L86-01 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT TROPONIN REAGENTS| ARCHITECT TROPONIN REAGENTS| LN 02K41-35 LOT UNKNOWN| LN 02K41-35 LOT UNKNOWN