BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3033003 · Received April 3, 2013

    Report

    Report Number
    1628664-2013-00081
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    September 30, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER ADDITIONAL REVIEW OF THE DATA IT WAS DETERMINED THAT THE ISSUE THE CUSTOMER REPORTED WAS CORRECTED BY THE REPLACEMENT OF THE OPTICS. REAGENT INVESTIGATION: REVIEW OF TICKET TRENDING DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY FOR EITHER OF THE LIKELY CAUSE REAGENT LOTS. THE TREND REVIEW DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOTS 94983UN12 AND 79223UN12. ACCEPTANCE CRITERIA WERE MET FOR BOTH REAGENT LOTS, WHICH INDICATE ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE LIKELY CAUSE LOTS ARE PERFORMING PER SPECIFICATION. A MALFUNCTION WAS NOT IDENTIFIED THE ISSUE THE CUSTOMER REPORTED WAS RESOLVED WITH THE OPTICS WERE REPLACED. ANALYZER (CMIA) READER INVESTIGATION: REVIEW OF 12 MONTHS OF QUALITY IMPACT DATA FOR FEBRUARY 2013 REPORTING PERIOD FOR THE CMIA READER, METAL CASE, TESTED IDENTIFIED NO TRIGGERS EXCEEDING THE UPPER CONTROL LIMITS OR TRENDS FOR TICKETS WITH REPLACEMENTS. REVIEWED THE ARCHITECT I2000SR INSTRUMENT SERVICE BULLETIN: ASSAY TROUBLESHOOTING WHICH PROVIDES ADEQUATE PROBABLE CAUSES, CORRECTIVE ACTIONS, AND TROUBLESHOOTING ACTIVITIES FOR THE OBSERVED PROBLEM: SINGLE POINT OR INTERMITTENT DEPRESSED CONCENTRATION (DOWNDROPPERS) FOR DIRECT ASSAYS, INCLUDING THE PROBABLE CAUSE OF A BAD OPTICS (CMIA) READER. THE CMIA READER WAS REPLACED DURING TROUBLESHOOTING OF THE ISSUE. THE CUSTOMER CONSIDERED THE OPTICS REPLACEMENT TO HAVE RESOLVED THE REPORTED IMPRECISION ISSUE AND NOTED THAT THE RLU VALUES ALSO RETURNED TO TYPICAL RANGES. THERE IS NO INDICATION OF A DEFICIENCY OF THE CMIA READER, METAL CASE, TESTED, HOWEVER, THE INFORMATION REASONABLY SUGGESTS A MALFUNCTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT STATED INTERMITTENT FALSE REACTIVE ARCHITECT STAT TROPONIN-I RESULTS OF APPROXIMATELY 0.1 NG/ML WERE GENERATED ON PATIENT SAMPLES THAT REPEATED ARCHITECT STAT TROPONIN-I NEGATIVE USING A LAB CUTOFF OF 0.04 NG/ML. THE ACCOUNT NOTICED THE FALSE REACTIVE ARCHITECT STAT TROPONIN-I RESULTS OCCUR WHEN CAL A OF THE CALIBRATION CURVE IS AT 800 TO >1000 RLU. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136966 ARCHITECT I2000SR ANALYZER MMI ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT 79223UN12, LIST 02K41-38| ARCHITECT STAT TROPONIN-I| ARCHITECT STAT TROPONIN-I| LOT 79223UN12, LIST 02K41-38| LOT 94983UN12, LIST 02K41-28| LOT 94983UN12, LIST 02K41-28