BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 12501067 · Received September 20, 2021

    Report

    Report Number
    3016438761-2021-00334
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 19, 2019
    Report Date
    November 22, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3016438761-10/06/21-003-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A1: PATIENT IDENTIFIER: MULTIPLE = SID (B)(6) . ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 = (B)(4).THIS SUPPLEMENTAL MDR IS BEING SENT TO INCLUDE THE SW VERSION. REFER TO SECTION D10: CONCOMITANT MEDICAL PRODUCTS FOR THIS UPDATE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE INADVERTENTLY WAS SUBMITTED ON MDR NUMBER 1628664-2019-00628. AND IS BEING SUBMITTED UNDER THIS MANUFACTURER REPORT NUMBER. ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. FS OBSERVED THE ICT MODULE EXPIRED ON 30AUG2019 AND THE MIXERS WERE NOT FUNCTIONING PROPERLY. THE ICT MODULE AND MIXERS WERE REPLACED BY FS. A REVIEW OF THE C802496 SERVICE HISTORY FOUND NO ADDITIONAL LIKELY CAUSES AND NO ADDITIONAL REPORTS OF INCONSISTENT OR ERRATIC RESULTS HAVE BEEN RECEIVED SINCE FS ADDRESSED THE ISSUE. A REVIEW OF HISTORICAL DATA FOR THE ICT MODULE (LN 09D28-03) AND MIXERS (LN 09D59-02) REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS REVEALED THAT THE CALCULATED ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT AND FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). LABELING WAS REVIEWED AND CONTAINS ADEQUATE INFORMATION ON MAINTENANCE AND TROUBLESHOOTING OF ERRATIC RESULTS. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED POTASSIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED (NORMAL RANGE: (3.5-5.1 MEQ/L): SID (B)(6): (B)(6) 2019 = 2.4 / 3.9 / 3.9 / 3.9. ADDITIONALLY, THE CUSTOMER REPORTED OTHER FALSELY DECREASED SODIUM, POTASSIUM, AND CHLORIDE RESULTS ON THE ARCHITECT C8000 ANALYZER ON MULTIPLE PATIENTS. RESULTS PROVIDED: SODIUM (NA) NORMAL RANGE: 136-145 MEQ/L SID (B)(6): (B)(6) 2019 = 137 / 138 / 139 / 136; SID (B)(6): (B)(6) 2019 = 136 / 141 / 141 / 142; SID (B)(6): (B)(6) 2019 = 132 / 137 / 137 / 137; SID (B)(6): (B)(6) 2019 = 140 / 140 / 142 / 141 / 144; SID (B)(6): (B)(6) 2019 = 140 / 138; SID (B)(6): (B)(6) 2019 = 131 / 141 / 142 / 143; SID (B)(6): (B)(6) 2019 = 138 / 142; SID (B)(6): (B)(6) 2019 = 128 / 139 / 137 / 137 / 140; SID (B)(6): (B)(6) 2019 = 137 / 138 / 139 / 138; POTASSIUM (K) NORMAL RANGE: 3.5-5.1 MEQ/L. SID (B)(6): (B)(6) 2019 = 3.7 / 3.7 / 3.7 / 3.6; SID (B)(6): (B)(6) 2019 = 3.7 / 4.0 / 4.0 / 4.0; SID (B)(6): (B)(6) 2019 = 3.5 / 4.7 / 4.7 / 4.7; SID (B)(6): (B)(6) 2019 = 3.5 / 3.5 / 3.6 / 3.6 / 4.6; SID (B)(6): (B)(6) 2019 = 2.8 / 3.8; SID (B)(6): (B)(6) 2019 = 3.4 / 4.3; SID (B)(6): (B)(6) 2019 = 2.2 / 2.5 / 2.4 / 2.4; SID (B)(6): (B)(6) 2019 = 2.6 / 2.6 / 2.6 / 2.6. CHLORIDE (CL) NORMAL RANGE: 98-107 MEQ/L. SID (B)(6): (B)(6) 2019 = 95 / 96 / 97 / 96; SID (B)(6): (B)(6) 2019 = 99 / 103 / 104 / 104; SID (B)(6): (B)(6) 2019 = 95 / 99 / 99 / 99; SID (B)(6): (B)(6) 2019 = 102 / 102 / 103 / 103 / 105; SID (B)(6): (B)(6) 2019 = 104 / 104; SID (B)(6): (B)(6) 2019 = 97 / 105 / 106 / 106; SID (B)(6): (B)(6) 2019 = 101 / 104; SID (B)(6): (B)(6) 2019 = 97 / 103 / 102 / 103 / 105; SID (B)(6): (B)(6) 2019 = 103 / 104 / 104 / 104. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED POTASSIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED (NORMAL RANGE: (3.5-5.1 MEQ/L): SID (B)(6), ON (B)(6) 2019 = 2.4 / 3.9 / 3.9 / 3.9 MEQ/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393478 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1G06-11 C802496 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARCH SW V9.10, 05F48-34, UNKNOWN