BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR ANALYZER

    MDR report key: 4103111 · Received September 19, 2014

    Report

    Report Number
    1628664-2014-00210
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. HIGH TEST RESULTS PATIENT PROBLEM; NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE COMPLETE SID IS: (B)(6). AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A SINGLE DEFINITIVE CAUSE WAS NOT IDENTIFIED. FIELD SERVICE CONSIDERED THE CA 19-9XR RESULT ISSUE RESOLVED THROUGH REPLACING THE VORTEXER, STABILIZED (PART NUMBER 7-76656-02) WHICH WAS REPLACED DURING TROUBLESHOOTING AND WAS CONSIDERED WORN OUT FROM NORMAL USE. HOWEVER SAMPLE HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR; ONLY 1 PATIENT RESULT WAS IMPACTED. MULTIPLE PARTS WERE REPLACED TO INCLUDE VORTEXER 1 AND WZ VALVES 1, 2 AND 3 AS A PRECAUTION. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE INSTRUMENT PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED CA19-9XR RESULT FOR ONE PATIENT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6). (NOTE: PREVIOUS VALUE: 2 U/ML); INITIAL: 55.7 U/ML, REPEAT 3.8 U/ML, 5.4 U/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582694 ARCHITECT I1000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT CA19-9 REAGENTS| LIST 02K91-25 LOT 33394M500| ARCHITECT CA19-9 REAGENTS| LIST 02K91-25 LOT 33394M500