BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 4173156 · Received October 15, 2014

    Report

    Report Number
    1628664-2014-00225
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 23, 2014
    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

    NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. TROUBLESHOOTING WAS PERFORMED AND THE SAMPLE PROBE WAS REPLACED. A PRODUCT LABELING REVIEW FOUND THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE TOTAL B-HCG ASSAY PACKAGE INSERT CONTAIN ADEQUATE INFORMATION FOR THE DESCRIBED ISSUE. A HISTORICAL/QUALITY DATA REVIEW AND COMPLAINT DATA REVIEW DID NOT IDENTIFY ANY ADVERSE TREND FOR PROBE ISSUES CAUSING DISCREPANT RESULTS. A SERVICE HISTORY REVIEW FOUND NO SERVICE HISTORY ISSUES FOR ARCHITECT I2000SR SERIAL (B)(4). NO ADDITIONAL DISCREPANT RESULT COMPLAINTS WERE FOUND TO HAVE BEEN DOCUMENTED FOR ARCHITECT I2000SR SERIAL (B)(4) SINCE THE PROBE WAS REPLACED. THE TOTAL B-HCG DISCREPANT RESULT ISSUE WAS RESOLVED THOUGH THE REPLACEMENT OF A USED PROBE. IN CONCLUSION, THE ARCHITECT I2000SR SERIAL (B)(4) IS PERFORMING ACCEPTABLY.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER DID NOT CONTAIN ENOUGH SPACES FOR ENTIRE ID. THE ENTIRE ID IS (B)(6). (B)(4) . A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. EVALUATION IN PROCESS.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSE POSITIVE BHCG OF 29.78 MIU/ML ON SAMPLE ID (B)(6) PROCESSED ON THE ARCHITECT I2000SR ANALYZER. THE SAME SAMPLE WAS REPEATED WITH THE NEGATIVE BHCG OF 1.20 MIU/ML ON THE ARCHITECT I2000SR. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655364 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT 41903UI00| LOT 41903UI00| BHCG LIST 07K78-25,| BHCG LIST 07K78-25