BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 18313381 · Received December 12, 2023

    Report

    Report Number
    3016438761-2023-00653
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 21, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED POSTAL CODE E1 (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. A REVIEW OF THE ARCHITECT I2000SR, SERIAL # (B)(6) SERVICE HISTORY, REVEALED NO ADDITIONAL ISSUES OF SPARKING (CHARRING/BURN) OBSERVED DUE TO A PART, REPORTED ON THE (B)(6). THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAINED ADEQUATE INFORMATION FOR THE TROUBLESHOOTING, REMOVAL, AND REPLACEMENT OF THE ARC PWR CRD NA250 (LIST NUMBER 08L13-01). THE REPLACEMENT OF THE ARC PWR CRD NA250 WAS THE ISSUE RESOLUTION. THE 2023 UL CERTIFICATION MEMO CONTAINS INFORMATION NOTING ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST ELECTRICAL SHOCK FROM THE EQUIPMENT. THE SPARKING (CHARRING/BURN) OBSERVED WAS LIMITED TO ARC PWR CRD NA250 (LIST NUMBER 08L13-01); THE SPARKING (CHARRING/BURN) DID NOT SPREAD TO OTHER PARTS OF THE MODULE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARC PWR CRD NA250 (LIST NUMBER 08L13-01) OR ARCHITECT I2000SR PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THE NO POWER TO SCC OF ARCHITECT I2000SR PROCESSING MODULE. THE CUSTOMER TRIED TO DISCONNECT POWER CABLE AND RECONNECT BACK ON. THE CUSTOMER HEAR NOISE FROM SCC OF ARCHITECT I2000SR PROCESSING MODULE. THE CUSTOMER NOTICED BURN MARK INSIDE THE ON CABLE CONNECTOR. THERE WAS NO REPORTED INJURY TO ANY USERS, NO PATIENT IMPACT, AND NO FACILITY DAMAGE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED THE NO POWER TO SCC OF ARCHITECT I2000SR PROCESSING MODULE. THE CUSTOMER TRIED TO DISCONNECT POWER CABLE AND RECONNECT BACK ON. THE CUSTOMER HEAR NOISE FROM SCC OF ARCHITECT I2000SR PROCESSING MODULE. THE CUSTOMER NOTICED BURN MARK INSIDE THE ON CABLE CONNECTOR. THERE WAS NO REPORTED INJURY TO ANY USERS, NO PATIENT IMPACT, AND NO FACILITY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383955 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown