BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 7809526 · Received August 23, 2018

    Report

    Report Number
    1628664-2018-01593
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    July 31, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE HAS BEEN CHANGED TO THE ARCHITECT HAVAB IGG ASSAY, LIST NUMBER 06C29, LOT 87317LI00. THE EVENT DOCUMENTED HAS BEEN ASSOCIATED WITH A PRODUCT RECALL. THE EVENT ASSOCIATED WITH THE UPDATED SUSPECT MEDICAL DEVICE (ARCHITECT HAVAB IGG ASSAY) IS NOT REPORTABLE PER 21CFR PART 806, AS THE PRODUCT HAS NOT BEEN DISTRIBUTED IN THE US. NO ADDITIONAL INFORMATION WILL BE PROVIDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED HAV IGG RESULTS WHILE USING THE ARCHITECT HAVAB IGG ASSAY ON THE ARCHITECT I2000SR ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (S/CO): 07/31/2018: INITIAL RESULT: 2.54 S/CO; RETESTS: 0.63 S/CO, 0.53 S/CO AND 1.15 S/CO; THE SPECIMEN WAS REPEATED IN A SERIES: 1.30 S/CO, 1.17 S/CO, 0.72 S/CO, 0.76 S/CO, AND 0.74 S/CO. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652108 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT HAVAB IGG| ARCHITECT HAVAB IGG| LN 06C29, LOT 87317LI00| LN 06C29, LOT 87317LI00