BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TACROLIMUS

    MDR report key: 2931702 · Received January 28, 2013

    Report

    Report Number
    1415939-2013-00025
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MLM
    PMA / PMN Number
    K070820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF HISTORICAL COMPLAINTS (BOTH TRENDING AND LOTS), ACCURACY TESTING AND A REVIEW OF LABELING. HISTORICAL COMPLAINT REVIEWS DID NOT IDENTIFY AN ADVERSE TREND. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 18267M500. ACCEPTANCE CRITERIA WAS MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE LIKELY CAUSE LOT PERFORMS PER SPECIFICATION. ADDITIONALLY, NO MALFUNCTION WAS IDENTIFIED SINCE RETEST OF THE ORIGINAL SAMPLE PRODUCED ACCEPTABLE RESULTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THROUGH TROUBLESHOOTING AT THE CUSTOMER SITE IT WAS DETERMINED THAT SAMPLE HANDLING ERROR OCCURRED WITH THE ORIGINAL 1:5 DILUTIONS WHICH CONTRIBUTED TO THE DISCREPANT RESULTS. NO ADDITIONAL ISSUES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ONE PATIENT WITH A FALSELY ELEVATED TACROLIMUS RESULT WHILE USING THE ARCHITECT I2000SR INSTRUMENT. THE CUSTOMER PROVIDED ONLY THE FOLLOWING RESULTS: (B)(6) 2013: > 30 NG/ML. THE CUSTOMER THEN DILUTED THE SAMPLE MANUALLY 1 TO 5, OBTAINING THE FOLLOWING RESULTS: (B)(6) 2013: 123.67 NG/ML; (B)(6) 2013: 109.74 NG/ML. THE RESULTS WERE QUESTIONED AND THE NEXT DAY THE CUSTOMER REPROCESSED THE SAMPLES: (B)(6) 2013: > 30 NG/ML. THE SAMPLE WAS REPROCESSED WITH A MANUAL DILUTION, OBTAINING THE FOLLOWING RESULTS: (B)(6) 2013: 23.26 NG/ML; (B)(6) 2013: 25.25 NG/ML. THERE WAS AN ERROR CNTRL MESSAGE OBTAINED WITH BOTH LOTS WITH ALL PATIENT RESULTS, BUT NO FURTHER INFORMATION ABOUT THESE DETAILS (OF THE CNTRL ERROR MESSAGE) WERE AVAILABLE. NO FURTHER PATIENT DETAILS ARE AVAILABLE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37691 ARCHITECT TACROLIMUS MLM ABBOTT LABORATORIES 18267M500

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 03M74-01 SN (B)(4)| ARCHITECT I2000SR ANALYZER| LN 03M74-01 SN (B)(4)| ARCHITECT I2000SR ANALYZER