BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    API® 20E TEST STRIP

    MDR report key: 7344955 · Received March 16, 2018

    Report

    Report Number
    3002769706-2018-00042
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Report Date
    April 23, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JSS
    UDI-DI
    03573026047818
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN EXTERNAL QUALITY CONTROL (QC )(RING TRIAL, RFB), THE CUSTOMER TESTED API® 20 E STRIPS AND OBTAINED A "BAD IDENTIFICATION" TO "KLEBSIELLA PNEUMONIAE" AT 97.3%. THE INTENDED IDENTIFICATION WAS "RAOULTELLA PLANTICOLA." AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED; HOWEVER, THE EXTERNAL QC TOOK PLACE ONE (1) YEAR AGO SO THE STRAIN IS NO LONGER AVAILABLE. IN ADDITION, THERE WAS NO RETURN OF THE API 20 E STRIPS AND THE LOT NUMBER OF THE BATCH WAS UNKNOWN. IN THE ABSENCE OF INFORMATION, INCLUDING CUSTOMER TROUBLESHOOTING , INVESTIGATION COULD NOT BE DONE INTERNALLY. CONSEQUENTLY, IT WAS NOT POSSIBLE TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE AND TO IMPLEMENT ACTION. NOTE: PRIOR TO 2001, THE NAME OF RAOULTELLA PLANTICOLA WAS "KLEBSIELLA PLANTICOLA". THE ARTICLE, "INTERNATIONAL JOURNAL OF SYSTEMATIC AND EVOLUTIONARY MICROBIOLOGY" (2001), 51, 925-932 BY M. DRANCOURT, TITLE "PHYLOGENETIC ANALYSES OF KLEBSIELLA SPECIES DELINEATE KLEBSIELLA AND RAOULTELLA GEN. NOV, WITH DESCRIPTION OF RAOULTELLA ORNITHINOLYTICA COMB. NOV., RAOULTELLA TERRIGENA COMB. NOV. AND RAOULTELLA PLANTICOLA COMB. NOV." MENTIONS: " CLUSTER II CONTAINED KLEBSIELLA ORNITHINOLYTICA, KLEBSIELLA PLANTICOLA, KLEBSIELLA TREVISANII AND KLEBSIELLA TERRIGENA, ORGANISMS CHARACTERIZED BY GROWTH AT 10°C AND UTILIZATION OF L-SORBOSE AS CARBON SOURCE. [...] THE NAME RAOULTELLA AS A GENUS NAME FOR SPECIES OF CLUSTER II AND EMENDED DEFINITIONS OF KLEBSIELLA SPECIES ARE PROPOSED." IN ADDITION, THE "RAOULTELLA PLANTICOLA" IS NOT IN THE DATABASE OF THE API 20 E STRIPS, SO IT IS NOT IDENTIFIABLE WITH THESE STRIPS. API 20 E STRIPS GAVE IDENTIFICATION TO "KLEBSIELLA PNEUMONIAE" BECAUSE IT IS A CLOSER STRAIN TO "KLEBSIELLA PLANTICOLA" (="RAOULTELLA PLANTICOLA").

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A MISIDENTIFICATION OF RAOULTELLA PLANTICOLA (EXTERNAL QC STRAIN) AS KLEBSIELLA PNEUMONIA IN ASSOCIATION WITH THE API® 20E TEST. NO ALTERNATE TEST METHOD OR CONFIRMATORY TESTING WAS PERFORMED BY THE CUSTOMER. THE EXTERNAL QC TESTING WAS PERFORMED ONE YEAR AGO; THE STRAIN IS NO LONGER AVAILABLE FOR RETEST. PRIOR TO 2001, THE NAME OF RAOULTELLA PLANTICOLA WAS KLEBSIELLA PLANTICOLA. THE BIOCHEMICAL CHARACTERISTICS BETWEEN RAOULTELLA PLANTICOLA AND KLEBSIELLA PNEUMONIA ARE SIMILAR. IT IS IMPORTANT TO NOTE THAT RAOULTELLA PLANTICOLA IS NOT IN THE API® 20E DATABASE; THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY RAOULTELLA PLANTICOLA THEAPI® 20E TEST STRIP. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE QC STRAIN. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189022 API® 20E TEST STRIP API® 20E TEST STRIP JSS BIOMERIEUX SA 03573026047818

    Patients

    Seq Age Sex Outcome Treatment
    1