BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 9889680 · Received March 27, 2020

    Report

    Report Number
    3016438761-2020-00014
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 9, 2020
    Report Date
    November 23, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3016438761-10/06/21-003-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, REVIEW OF PRODUCT HISTORICAL DATA, DEVICE HISTORY RECORD REVIEW AND A REVIEW OF LABELING. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED MULTIPLE TROUBLESHOOTING TASKS INCLUDING THE REPLACEMENT OF THE VALVE, MANIFOLD KIT (PN 7-77612-03), WHICH RESOLVED THE ISSUE. A REVIEW OF THE ANALYZERS SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT, AND NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE PART WAS REPLACED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE VALVE, MANIFOLD KIT (PN 7-77612-03). A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE ARCHITECT I2000SR. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. MANUFACTURING DOCUMENTATION WAS REVIEWED, AND NO ISSUES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I2000SR PROCESSING MODULE OR THE VALVE, MANIFOLD KIT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A1: PATIENT IDENTIFIER- MULTIPLE = SID (B)(6). COMPLETE INFORMATION FOR SECTION 9: RCR # 3016438761-10/06/21-003-C. FURTHER INVESTIGATION DETERMINED THIS EVENT WAS IMPACTED BY AN ISSUE IDENTIFIED IN ARCHITECT SOFTWARE VERSIONS 9.41 OR EARLIER. A PRODUCT CORRECTION LETTER WAS ISSUED ON 29SEP2021 TO ALL ARCHITECT CUSTOMERS WHO HAVE INSTALLED ARCHITECT PROCESSING MODULES, NOTIFYING THEM OF THE ISSUES IN ARCHITECT SOFTWARE VERSIONS 9.41 AND EARLIER. THE PRODUCT CORRECTION LETTER INFORMS THE CUSTOMER THAT AN ABBOTT REPRESENTATIVE WILL SCHEDULE A MANDATORY UPGRADE OF THEIR SYSTEM TO ARCHITECT SOFTWARE VERSION 9.45 OR 9.5.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION H9: CORRECTION/REMOVAL REPORTING NUMBER = 3016438761-10/06/21-003-C. THIS SUPPLEMENTAL MDR IS BEING SENT TO INCLUDE THE SW VERSION. REFER TO SECTION D10: CONCOMITANT MEDICAL PRODUCTS FOR THIS UPDATE

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER- MULTIPLE = (B)(6). ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE NONREACTIVE (B)(6) RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR. THE FOLLOWING DATA WAS PROVIDED FOR THE TWO PATIENTS: (B)(6): INITIAL: 0.00 IU/ML (NONREACTIVE), RETEST 38.81 IU/ML (REACTIVE). THE CUSTOMER REPORTED THE PATIENT TEST HISTORY WAS POSITIVE AT ABOUT 30 IU/ML. (B)(6): INITIAL: 0.00 IU/ML(NONREACTIVE), RETEST: 27.66 IU/ML(REACTIVE), 27.22 IU/ML(REACTIVE), THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353827 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARCH HBSAG RGT 1X500, 06C36-35, UNKNOWN| ARCH SW V9.10, 05F48-34, UNKNOWN| ARCHITECT HBSAG| ARCHITECT HBSAG| LIST 06C36-35, LOT UNKNOWN| LIST 06C36-35, LOT UNKNOWN