BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 2800776 · Received October 22, 2012

    Report

    Report Number
    1415939-2012-02045
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    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 (B)(4) 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT UPDATED FROM UNKNOWN TO (B)(6) 2012. CONCOMITANT MEDICAL PRODUCTS WAS UPDATED TO ELIMINATE ARCHITECT I2000SR, SERIAL (B)(4) AN EVALUATION IS 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
    1 ARCHITECT STAT TROPONIN-I MMI ABBOTT LABORATORIES 79223UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR, LIST 03M74-02| SERIAL (B)(4)| SERIAL (B)(4)| ARCHITECT I2000SR, LIST 03M74-02,