BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IVANCOMYCIN

    MDR report key: 2874023 · Received December 14, 2012

    Report

    Report Number
    3002809144-2012-00169
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 12, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THIS ISSUE IS NO LONGER RELATED TO CORRECTION AND REMOVAL NUMBER 3002809144-9/15/10-001-C.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SECOND QUARTER, 2012. THE ADDITIONAL SAMPLE CENTRIFUGATION AS INSTRUCTED IN PRODUCT CORRECTION LETTER OF FA13SEP2010 WILL CONTINUE TO BE FOLLOWED BY US CUSTOMERS. SUBMISSION FOR THE US 510K CLEARANCE OF THE NEW PRODUCT WAS DETERMINED TO OCCUR THE SECOND QUARTER OF 2012.

    Description of Event or Problem · 1

    REPORTABLE RATIONALE: THE CUSTOMER GENERATED FALSELY ELEVATED VANCOMYCIN RESULTS FROOM ONE PATIENT SAMPLE ((B)(6)) WHILE USING THE ARCHITECT IVANCOMYCIN ASSAY. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL >100 UG/ML, 1:3 DILUTED: 18 THE SPECIMEN WAS RETESTED UNDILUTED AND GENERATED A RESULT OF >100 AGAIN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT IVANCOMYCIN LEH ABBOTT GERMANY 01212E000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR 01L86-40, SN (B)(4)| ARCHITECT I1000SR 01L86-40, SN (B)(4)