BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 983682 · Received January 24, 2008

    Report

    Report Number
    1628664-2008-00022
    Event Type
    Other
    Date Received
    January 24, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 4, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CDZ
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE ACCOUNT STATED THEY WERE RECEIVING INCONSISTENT BHCG RESULTS. CUSTOMER STATED THAT THEY HAD NO PROBLEMS WITH OTHER ASSAYS. THE COMPLAINT TEXT INDICATES A PHYSICIAN QUESTIONED THE RESULT ON THE FIRST PT, AS THE PREVIOUS RESULT WAS MUCH HIGHER. NO IMPACT TO PT MGMT WAS REPORTED. PER THE COMPLAINT TEXT THE CUSTOMER'S STAT PROBE HAS NEVER BEEN REPLACED. THE CSS INSTRUCTED THE CUSTOMER TO REPLACE AND CALIBRATE THE STAT PROBE AND TO ALSO REPLACE ALL 6 WASH ZONE PROBES. THE CUSTOMER PERFORMED THE REQUESTED TROUBLESHOOTING HOWEVER THE CUSTOMER STILL EXPERIENCED AN ISSUE NEAR THE HIGH LIMIT OF THE ASSAY. THE CUSTOMER LAST CALIBRATED THE ASSAY (B)(6)2008 USING REAGENT LOT NUMBERS (B)(4) AND (B)(4).AND CALIBRATOR LOT NUMBERS (B)(4). AND (B)(4). THE CSS INSTRUCTED THE CUSTOMER TO LOAD THE ROUTINE BHCG ASSAY TO CHECK THE PERFORMANCE OF THE ASSAY. THE COMPLAINT TEXT STATES THE CUSTOMER PERFORMED THE REQUESTED TROUBLESHOOTING BUT DID NOT GET RESULTS IN THE RANGE OF THE HIGH LIMIT. THE COMPLAINT INDICATED THE LOW AND MIDDLE VALUES RECOVERED WERE ACCEPTABLE. THE CSS WAS TO FOLLOW-UP WITH THE CUSTOMER. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEY ARE HAVING ISSUES WITH REPRODUCIBILITY WHEN TESTING PTS WITH THE ARCHITECT BHCG ASSAY. THE CUSTOMER STATES THAT THE STAT BHCG ASSAY GENERATED A RESULT OF 175,000 MIU/ML FOR ONE PT, WHICH TESTED 14,900 MIU/ML ON A SAMPLE DRAWN 2 DAYS LATER THAT WAS QUESTIONED BY A PHYSICIAN. THIS SAMPLE WAS REPEATED YIELDING A RESULT OF 15,000 MIU/ML. A RERUN OF THE SAMPLE DILUTED 1:15 GENERATED A RESULT OF 136,000 MIU/ML. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY ANALYZER CDZ ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other (B)(4)