BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2994144 · Received March 8, 2013

    Report

    Report Number
    1628664-2013-00054
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE ARCHITECT I2000SR ANALYZER SYSTEM LOGS AND DATABASE FOR SERIAL NUMBER (B)(4) FOUND NO AFP ASSAY RESULTS FOR SAMPLE ID (B)(6). THE RESULT LOG SHOWED THAT AN AFP AND A TOTAL B-HCG TEST REQUESTED ON SAMPLE ID (B)(6) BOTH WENT TO EXCEPTIONS WITH ERROR CODE 0211 - UNABLE TO PROCESS TEST(S), SAMPLE ID (B)(6) DOES NOT MATCH SCANNED SAMPLE ID (B)(6). THIS INDICATES THE SAMPLES WERE NEVER ASPIRATED AND NO RESULTS WERE GENERATED. AN EXCEPTION IS A TEST ORDER THAT FAILED TO COMPLETE. RESULTS ARE NOT REPORTED AND OPERATOR INTERVENTION IS REQUIRED. A REVIEW OF THE SYSTEM DATABASE FOR ANOTHER I2000SR, SERIAL NUMBER (B)(4), IN THE LAB FOUND NO AFP RESULTS. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE SEARCH IDENTIFIED NO OTHER COMPLAINTS RELATED TO INCORRECT RESULTS BEING TRANSMITTED FROM AN ARCHITECT SYSTEM AND DISPLAYED IN THE LABORATORY INFORMATION SYSTEM (LIS) OF A CUSTOMER. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES INFORMATION TO ADDRESS THE CURRENT CUSTOMER CONCERN. BASED ON THE RESULTS OF THE CURRENT EVALUATION, THE INFORMATION DOES NOT INDICATE A MALFUNCTION OF THE ARCHITECT SYSTEM SOFTWARE VERSION 7.00. THE SYSTEM IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS AN INCIDENT IN WHICH IT IS ALLEGED THAT THE ARCHITECT I2000SR ANALYZER POPULATED AN INCORRECT VALUE TO THE CUSTOMER'S LIS (CLINISIS) FOR THE AFP ASSAY FOR ONE PATIENT SAMPLE ON (B)(6) 2013 FOR (B)(6). THE CUSTOMER ALLEGES THAT THE ARCHITECT I2000SR ANALYZER SENT OVER A VALUE OF 3704 IN PLACE OF THE ACTUAL ASSAY RESULT. IT IS UNKNOWN WHAT THIS NUMBER IS OR WHERE IT ORIGINATED FROM. IN ATTEMPTING TO TROUBLESHOOT THE ISSUE, ABBOTT PERSONNEL RETRIEVED THE INSTRUMENT LOGS BUT FOUND THAT THE INFORMATION IN THE LOGS ONLY WENT BACK TO (B)(6) 2013 AND THE DATA FROM THE INCIDENT DATE COULD NOT BE RETRIEVED FOR ANALYSIS. IN REVIEWING RESULTS LOGS, IT WAS FOUND THAT THE AFP ASSAY HAD FAILED WITH EXCEPTIONS (RESULTS NOT GENERATED) TWICE FOR THIS SAMPLE REGARDING TEST PROCESSING AND SAMPLE IDENTIFICATION MISMATCHES. THE SAMPLE WAS NOT RETESTED A THIRD TIME. THERE IS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99107 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT AFP ASSAY LN: 03P36| ARCHITECT SOFTWARE VERSION 7.00 LN:05F48-25| ARCHITECT AFP ASSAY LN: 03P36 LOT: UNK| ARCHITECT SOFTWARE VERSION 7.00 LN:05F48-25