BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENEXPERT SOFTWARE

    MDR report key: 2160309 · Received April 28, 2011

    Report

    Report Number
    3004530258-2011-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CEPHEID
    Product Code
    OQW
    PMA / PMN Number
    K103770
    Removal / Correction Number
    3004530258:4/12/11-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO RISK OF INJURY TO PT DURING THE ORIGINATING EVENT AT (B)(6) (REPORTING SITE, (B)(4)) BECAUSE THE SITE COMPARES ALL TEST RESULTS TO TEST ORDERS BY PT NAME, SAMPLE ID TEST ORDER NUMBER AND CARTRIDGE NUMBER. THE TRANSPOSITION OF DATA WAS DETECTED BEFORE PT RESULTS WERE REPORTED. THE EXACT CONFIGURATION THAT ALLOWED THE EVENT TO OCCUR WAS IDENTIFIED (INFINITY 48 SYSTEMS WITH GENEXPERT 4.1A USING HOST QUERY TEST ORDER DOWNLOAD CONFIGURATION AND BATCH LOADING). NO OTHER SITES USED THIS EXACT CONFIGURATION AND THEREFORE, COULD NOT HAVE EXPERIENCED THE MALFUNCTION THAT MAY HAVE RESULTED IN A DISCREPANT PT RESULT REPORT. ALL UNITED STATES CONSIGNEES WERE CONTACTED BY PHONE 04/01/2011. ALL UNITED STATES CONSIGNEES RECEIVED A COPY OF EMAIL 04/01/2011. ALL XUS CUSTOMERS WERE NOTIFIED BY 04/08/2011. EACH CONSIGNEE WERE SENT A HARD COPY CORRECTIVE ACTION NOTIFICATION BY (B)(4) BY 04/27/2011. SUMMARY OF EVAL: EVAL OF THE (B)(6) DISCREPANT SPECIMEN RESULTS INCLUDED: REVIEW OF CUSTOMER COMPLAINTS FOR SIMILAR COMPLAINTS - NONE FOUND. REVIEW OF UNRESOLVED ANOMALY LIST FOR SIMILAR ISSUE - NONE FOUND. TRACING CHRONOLOGICAL SEQUENCE OF EVENTS OF THE DATA HAND-OFF POINTS FROM LIS TO INFINITY FOR TEST ORDER DOWNLOADS, RUNNING CARTRIDGE, AND UPLOAD OF TEST RESULTS FROM INFINITY TO LIS. WALKTHROUGH OF DATABASE RECORDS AND THEIR LINKAGES. COOL WALKTHROUGHS FOR BOTH LIS TEST ORDER DOWNLOAD PATH AND PATH FOR TEST RESULT UPLOAD TO LIS. ATTEMPTS TO REPRODUCE THE EVENTS BY RUNNING (B)(6) SPECIFIC LIS CONFIGURATION USING BATCH LOADING OF CARTRIDGES. BY EVALUATING THE DATA HAND-OFF POINTS AND SEEING HOW THE DATABASE RECORDS WERE LINKING THE DATA WITHIN THE DATABASE, THE SCENARIO WAS ABLE TO BE REPRODUCED USING THE SPECIFIC LIS CONFIGURATION. THE COMBINATION OF USING HOST QUERY LIS CONFIGURATION WHERE THE SCANNING OF THE SAMPLE ID REQUESTS INFO FROM THE LIS AND THE RAPID LOADING OF CARTRIDGES BEFORE THE LIS TEST ORDER HAD DOWNLOADED WERE DETERMINED TO BE THE ROOT CAUSE. CORRECTIVE ACTION HAS BEEN TAKEN WITH CUSTOMERS AND PREVENTIVE ACTION WILL INCLUDE NEW SOFTWARE RELEASE. NO PTS WERE MISDIAGNOSED DUE TO THIS MALFUNCTION. ONLY ONE CONSIGNEE SITE WAS CONFIGURED IN SUCH A WAY AS TO CAUSE THE MALFUNCTION. BECAUSE INFINITY RESULTS WERE ALWAYS COMPARED TO LIS TEST RESULTS MANUALLY, NO PT DATA WERE AFFECTED AND THE SITE DID NOT REPORT ANY DISCREPANT RESULTS.

    Description of Event or Problem · 1

    GENEXPERT INFINITY XPERTISE SOFTWARE, VERSION 4.1A, ALLOWS USER TO ENTER TEST ORDERS FASTER THAN THE REQUEST FOR LAB INFO SYS (LIS) ORDERS CAN BE PROCESSED. IN COMPLAINT (B)(4), A CUSTOMER (B)(6) REPORTED VISUAL OBSERVATION OF MISMATCHED PT ID AND SAMPLE RESULTS. UPON FURTHER INVESTIGATION, CEPHEID FIELD SUPPORT DETERMINED THAT WHEN BATCH LOADING CARTRIDGES ONTO THE GENEXPERT INFINITY-48, IF INPUT DATA (PATIENT ID, SAMPLE ID, AND CARTRIDGE ID) ARE ADDED VERY QUICKLY, THE SYSTEM MAY NOT PAIR THE PT SAMPLE WITH CORRECT LIS TEST ORDER. THE INCORRECT PAIRING OF LIS ORDERED PT ID TO A SAMPLE ID CAN OCCUR IF SAMPLES ARE PROCESSED FASTER THAN LIS ORDERS ARE DOWNLOADED. FOR EXAMPLE, WHEN SAMPLE ID #1 IS SCANNED, THE LIS ORDER DOWNLOAD STARTS, BUT THE TEST CAN BE STARTED BEFORE THE DOWNLOAD HAS COMPLETED. IF SAMPLE ID #2 IS SCANNED BEFORE THE FIRST LIS ORDER DOWNLOAD COMPLETES, THE SAMPLE ID #2 MAY BE INCORRECTLY PAIRED TO THE FIRST LIS ORDERED PT ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENEXPERT SOFTWARE GENEXPERT SOFTWARE OQW CEPHEID INFINITY-48 V4.1A 020411A REV C

    Patients

    Seq Age Sex Outcome Treatment
    1