BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IVANCOMYCIN

    MDR report key: 3771062 · Received April 24, 2014

    Report

    Report Number
    3002809144-2014-00122
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LEH
    PMA / PMN Number
    K072036
    Removal / Correction Number
    3002809144-9/15/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (TEST RESULT); (NO CONSEQUENCES OR IMPACT TO PATIENT). HIGH TEST RESULTS. AN EVALUATION HAS DETERMINED THAT THERE IS A POTENTIAL FOR THE ARCHITECT VANCOMYCIN ASSAY TO GENERATE FALSELY ELEVATED RESULTS DUE TO SAMPLE OR SAMPLE HANDLING ISSUES CAUSING INTERFERENCE. IN RESPONSE TO THIS ISSUE A PRODUCT CORRECTION LETTER WAS SENT TO THE CUSTOMERS WITH SPECIFIC INSTRUCTIONS TO CONTINUE FOLLOWING ALL SAMPLE HANDLING INSTRUCTIONS PER THE PACKAGE INSERT AND TO FOLLOW THE ADDITIONAL CENTRIFUGATION INSTRUCTIONS INCLUDED IN THE PRODUCT CORRECTION LETTER. FURTHER INVESTIGATION DETERMINED THE ROOT CAUSE OF ARCHITECT IVANCOMYCIN (LIST NUMBER 01P30-25) FOR FALSELY ELEVATED RESULTS IS DUE TO THE TRACER DILUENT FORMULATION. THE FORMULATION DOES NOT ADEQUATELY PROTECT AGAINST SPECIMEN CONTAMINATION. THE INVESTIGATION DETERMINED, AND SUBSEQUENT VERIFICATION CONFIRMED, A CHANGE TO THE CONJUGATE DILUENT WILL CORRECT THE ISSUE. A PRODUCT INFORMATION LETTER REGARDING THIS NEW REAGENT WAS ISSUED ON MARCH 21, 2012 INFORMING EX-US CUSTOMERS THAT THE NEW REAGENT FORMULATION, LIST NUMBER 1P30-27 WILL BE AVAILABLE. THE ADDITIONAL SAMPLE CENTRIFUGATION AS INSTRUCTED IN PRODUCT CORRECTION LETTER OF FA13SEP2010 WILL CONTINUE TO BE FOLLOWED BY US CUSTOMERS, WHILE THE SUBMISSION FOR THE US 510K CLEARANCE AND LAUNCH OF THE NEW PRODUCT ARE STILL PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ARCHITECT IVANCOMYCIN RESULT OF >100 UG/ML WAS GENERATED FROM A MODERATELY ICTERIC PEDIATRIC SAMPLE. THE CUSTOMER RETESTED THE SAMPLE DILUTED AND THE RESULT WAS 43 UG/ML. THE CUSTOMER WAS UNSURE WHICH RESULT TO REPORT. THE CUSTOMER WAS TRAINED REGARDING BILIRUBIN AS A POSSIBLE INTERFERING SUBSTANCE PER THE PACKAGE INSERT. THE CUSTOMER FOLLOWED LABORATORY PROTOCOL BY DILUTING THE SAMPLE PER THE PACKAGE INSERT AND INCLUDING A NOTE THAT THE SAMPLE WAS MODERATELY ICTERIC. THE CUSTOMER DID NOT FOLLOW THE PRODUCT CORRECTION LETTER OF FA13SEP2010 REGARDING SPINNING AND PROCESSING THE SAMPLE. THE CUSTOMER WAS INSTRUCTED TO FOLLOW THE LETTER OF FA13SEP2010. NO MEDICAL DECISION WAS MADE BASED ON THE >100 UG/ML RESULT. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250297 ARCHITECT IVANCOMYCIN VANCOMYCIN LEH ABBOTT GERMANY 00613K000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR 03M74-02 SN (B)(4)