BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 2070005 · Received April 26, 2011

    Report

    Report Number
    3005094123-2011-00003
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: WASH ZONE MANIFOLDS, WASH ZONE 2 PROBES. A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE ACCOUNT. THE FSR REPLACED THE WASH ZONE MANIFOLDS, REPLACED THE PROBES IN WASH ZONE 2 AND CLEANED THE PROCESS PATH AFTER WHICH NO FURTHER ISSUES WERE REPORTED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ABBOTT ARCHITECT TOTAL B-HCG REAGENT, (B)(4) MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME ABBOTT ARCHITECT I2000 ANALYZER, (B)(4) MANUFACTURING SITE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT AN INITIAL ARCHITECT TOTAL B-HCG RESULT OF 2.88 MIU/ML WAS GENERATED. THE SAMPLE WAS REPEATED 3 TIMES WITH THE FOLLOWING RESULTS: 31.71 MIU/ML, 1.92 MIU/ML, AND 2.42 MIU/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 LN 3M74-01 SN (B)(4)| ARCHITECT TOTAL B-HCG 7K78-25 LOT UNKNOWN| ARCHITECT TOTAL B-HCG 7K78-25 LOT UNKNOWN