BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KIT AST-P605

    MDR report key: 5409626 · Received February 4, 2016

    Report

    Report Number
    1950204-2016-00016
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Report Date
    January 27, 2016
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. EVALUATION OF THE MANUFACTURING QC BATCH RECORDS FOR VITEK 2 AST-P605 LOT 485368220 INDICATED THE LOT PASSED QC PERFORMANCE TESTING FOR MINOCYCLINE. THERE WERE NO ATYPICAL RESULTS FOR PACKAGE INSERT STRAIN ENTEROCOCCUS FAECALIS ATCC 29212 TM ON INITIAL TESTING. ALL REPLICATES OF E. FAECALIS ATCC 29212 GAVE ACCEPTABLE MIC RESULTS OF 1 ON INITIAL TESTING (EXPECTED RESULT IS 1 - 4). A GRAPH REVIEW OF ORIGINAL QC PERFORMANCE TESTING WAS PERFORMED AND THE LOW WELL OF MINOCYCLINE (WELL 35 MNO 0.125) EXHIBITED GROWTH THAT WAS DECREASED, THOUGH IN RANGE, WHEN COMPARED TO HISTORICAL DATA. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE WERE NO DOCUMENTED ERRORS ASSOCIATED WITH THE MANUFACTURING OF THE MINOCYCLINE WELLS. INVESTIGATIONAL TESTING INCLUDED: AST P605 (CUSTOMER LOT 485368220): 6 OF 40 TESTS PROVIDED RESULTS OF MIC <=0.5. THE REMAINING TESTS WERE WITHIN RANGE (MIC = 1). AST P605 (RANDOM LOT 485372420): ALL TESTS PROVIDED ACCEPTABLE RESULTS OF MIC = 2. AST P605 (RANDOM LOT 485382920): ALL TESTS PROVIDED ACCEPTABLE RESULTS OF MIC = 2. A GRAPH REVIEW WAS PERFORMED AND IDENTIFIED THE LOW WELL OF MINOCYCLINE (WELL #35 MNO 0.125) IN THE CUSTOMER LOT EXHIBITED GROWTH THAT WAS DECREASED WHEN COMPARED TO THE RANDOM LOTS THAT WERE TESTED. THE DECREASED GROWTH WAS LIMITED TO THE LOW MINOCYCLINE WELL (WELL 35 MNO 0.125) OF THIS LOT. THE LOW WELL OF MINOCYCLINE IS RESPONSIBLE FOR RESULTS RANGING FROM 0.5 - 4. A GRAPH REVIEW WAS PERFORMED ON INITIAL QC PERFORMANCE DATA FOR ALL OTHER ANTIBIOTICS INCLUDED ON AST-P605 LOT 485368220. NO SHIFTS OR TRENDS IN QC TESTING RESULTS WERE SEEN WITH ANY OTHER ANTIBIOTIC INCLUDED ON THE CARD. IN ADDITION, GRAPH REVIEW AND MIC EVALUATION OF THE INVESTIGATION TESTING PERFORMED ON E. FAECALIS ATCC 29212 CONFIRMED ALL ANTIBIOTICS, WITH THE EXCEPTION OF MINOCYCLINE, GAVE ACCEPTABLE IN-RANGE MIC'S ACCORDING TO INTERNAL MEDIA TEST SPECIFICATIONS. THE IDENTIFIED ISSUE IS LIMITED TO THE MINOCYCLINE ANTIBIOTIC AND THE AST-P605 TEST KIT LOT 485368220. A FIELD SAFETY CORRECTIVE ACTION (FSCA) 2878 HAS BEEN ISSUED TO IMPACTED SUBSIDIARIES TO NOTIFY AFFECTED CUSTOMERS OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A MINOCYCLINE QC FAILURE OORL (OUT OF RANGE LOW) FOR ENTEROCOCCUS FAECALIS ATCC 29212 TM WHEN TESTED WITH THE VITEK 2 AST-P605 TEST KIT. NO DETAILS REGARDING MIC VALUES (ACTUAL VS. EXPECTED) WERE PROVIDED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMERIEUX THAT THE MINOCYCLINE QC FAILURE LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMEREUX FOR INTERNAL INVESTIGATION. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67884 VITEK® 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KIT AST-P605 VITEK® 2 AST-P605 LON BIOMÉRIEUX, INC. 485368220

    Patients

    Seq Age Sex Outcome Treatment
    1