BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 5438998 · Received February 16, 2016

    Report

    Report Number
    1628664-2016-00034
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    December 28, 2015
    Report Date
    February 24, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES, A REVIEW OF LABELING, AND A REVIEW OF HISTORICAL DATA. THE CUSTOMER OBSERVED ERROR CODE 3700 [UNABLE TO PROCESS TEST (X) WASH ASPIRATION ERROR FOR PROBE(S) (Y)] ON THEIR ARCHITECT I2000SR SERIAL NUMBER (B)(4) ON (B)(6) 2015. SERVICE CLEANED/ADJUSTED THE TUBING AND VALVES OF THE ACCUMULATOR, VACUUM ASM (PART NUMBER 7-78400-01) AND THE VALVE, DRAIN, VACUUM VESSEL (ROHS) PN 7-76447-01 TO RESOLVE THE ISSUE. RETURNS WERE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION FROM 28DEC2015 INDICATES THAT THE OPERATOR DELETED ERROR CODE 3700 EACH OF THE 49 TIMES IT WAS GENERATED ON THAT DATE AND CONTINUED TESTING WITHOUT TROUBLESHOOTING THE ERROR CODE PER THE ARCHITECT SYSTEM OPERATIONS MANUAL. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES INFORMATION FOR THE TROUBLESHOOTING AND MAINTENANCE CONCERNING ERRATIC / DISCREPANT RESULTS. A REVIEW FOR SIMILAR COMPLAINTS IDENTIFIED NO TRENDS FOR DISCREPANT/ERRATIC RESULTS ASSOCIATED WITH THE ACCUMULATOR, VACUUM ASM (PART NUMBER 7-78400-01) NOR THE VALVE, DRAIN, VACUUM VESSEL (ROHS) PN 7-76447-01. A REVIEW OF THE I2000SR COMPLAINT HISTORY REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE ERRATIC RESULT ISSUE DESCRIBED IN THIS COMPLAINT. BASED ON THIS INVESTIGATION, IT HAS BEEN DETERMINED THAT THE ACCUMULATOR, VACUUM ASM (PART NUMBER 7-78400-01), THE VALVE, DRAIN, VACUUM VESSEL (ROHS) PN 7-76447-01, AND THE ARCHITECT I2000SR SERIAL NUMBER (B)(4) ARE PERFORMING ACCEPTABLY AND NO PRODUCT ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ERROR CODE 3700 [UNABLE TO PROCESS TEST (X) WASH ASPIRATION ERROR FOR PROBE(S) (Y)] ON THEIR ARCHITECT ANALYZER ON (B)(6) 2015. THE CUSTOMER DELETED THE ERRORS AND CONTINUED TO WORK ON THIS ANALYZER GENERATING PATIENT RESULTS. AFTER THE ABBOTT FIELD SERVICE ENGINEER WAS ON SITE THE CUSTOMER DECIDED TO REVIEW THE (B)(6) 2015 RESULTS AND RETEST THEM WITH SEVERAL COMING OUT COMPLETELY DIFFERENT. THE FALSELY DECREASED RESULTS PROVIDED WERE: AFP INITIAL 1.52NG/ML / 4.2 (NORMAL RANGE 0.89-8.78NG/ML); TROPONIN = 8 / 37PG/ML (CUSTOMER'S DIAGNOSTIC CUTOFF IS 34PG/ML). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95500 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1