BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2183175 · Received July 28, 2011

    Report

    Report Number
    1628664-2011-00550
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    WHILE TROUBLE SHOOTING THE ISSUE, THE CUSTOMER WAS INSTRUCTED TO REPLACE THE SAMPLE PROBE AND THE FALSE REACTIVE RESULT WAS NON-REACTIVE UPON REPEATING THE TEST. THE CUSTOMER REQUESTED ABBOTT SERVICE TO INSPECT THE ANALYZER. THE ANALYZER WAS INSPECTED, A GRAVIMETRIC DIAGNOSTIC PROCEDURE WAS PERFORMED TO INSPECT SOME PARTS OF THE ANALYZER AND THE PROCEDURE WAS ACCEPTABLE. THE DAILY MAINTENANCE PASSED AND THE QUALITY CONTROL RESULTS WERE WITHIN THE CUSTOMERS ESTABLISHED RANGES. A REVIEW OF THE TRENDING DATA DID NOT IDENTIFY A PRODUCT ISSUE OR ADVERSE TREND ASSOCIATED WITH THIS ISSUE. THE CUSTOMER, HOWEVER, WAS REFERRED TO THE OPERATORS MANUAL WHICH CONTAINED THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR SUCH AN ISSUE (PROBE TIP IS BENT OR DAMAGED, PIPETTE PROBES ARE NOT STRAIGHT, PROBE IS NOT CORRECTLY POSITIONED). THE ARCHITECT CMV IGM ASSAY PACKAGE INSERT SUGGESTED ADDITIONAL TESTING OR USE OTHER DATA TO CONFIRM THE RESULTS. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY WAS IDENTIFIED RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PATIENT SAMPLE ID OF (B)(6) GENERATED A FALSE POSITIVE RESULT OF 1.13 S/CO FOR THE ARCHITECT CMV-IGM ASSAY. THE SAME PATIENT SAMPLE WAS RETESTED ON A LATER DATE AND THE SAME INSTRUMENT AFTER REPLACING THE SAMPLE PROBE WITH A NEGATIVE RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CMV-IGM (B)(4)| CMV IGM (B)(4)