BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 8442435 · Received March 21, 2019

    Report

    Report Number
    1628664-2019-00238
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED FOR THE CUSTOMER ISSUE AND INCLUDED A REVIEW OF THE COMPLAINT TEXT, TROUBLESHOOTING, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF SERVICE HISTORY, AND A REVIEW OF LABELING. WHILE TROUBLESHOOTING THE ISSUE, SERVICE OBSERVED THAT THE VALVES WERE NOT DISPENSING PROPERLY AND PUMP, VACUUM SHOWED LOSS OF PRESSURE. SERVICE DETERMINED THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03, PUMP, VACUUM (ROHS)_PART NUMBER 7-77795-02 AS WELL AS THE RV TRANSPORT SENSOR BD, SELF CALIBRATING (ROHS)_PART NUMBER 7-900155-01 WERE THE LIKELY CAUSE AND CHANGED THE PARTS. A 12- MONTH SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED NO ADVERSE TRENDS OF VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-03, PUMP, VACUUM (ROHS)_PART NUMBER 7-77795-02 AND RV TRANSPORT SENSOR BD, SELF CALIBRATING (ROHS)_PART NUMBER 7-900155-01. NO SYSTEMIC ISSUES OR ADVERSE TRENDS WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE REACTIVE RESULTS FOR HBSAG AND (B)(6) RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR (SN (B)(4)). THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT OF 1.73 AND RETEST RESULTS OF 1.69 AND 1.66 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234947 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1