BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3897760 · Received June 26, 2014

    Report

    Report Number
    1628664-2014-00124
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZP
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FALSE NEGATIVE ANTI HBC RESULT WAS GENERATED FOR ONE PATIENT ON THE ARCHITECT I2000SR ANALYZER. FIELD SERVICE PERFORMED TROUBLESHOOTING AND DETERMINED THE PROBABLE CAUSE WAS THE WASH BUFFER DISPENSE AT THE WASH ZONES WAS INADEQUATE. SERVICE REPLACED THE VALVE MANIFOLD KITS TO RESOLVE THE ISSUE. NO FURTHER DISCREPANT RESULTS WERE NOTED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A (B)(6) RESULT OF (B)(6) WAS GENERATED. THE SAMPLE WAS REPEATED MULTIPLE TIMES WITH RESULTS IN THE RANGE OF (B)(6). THE PATIENT HAD BEEN RUN ON ANOTHER ANALYZER WITH A (B)(6) RESULT. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374091 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER MZP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT UNKNOWN| LOT UNKNOWN| ARCHITECT (B)(4)| ARCHITECT (B)(4)