BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    API® RAPIDEC® CARBA NP

    MDR report key: 8304917 · Received February 5, 2019

    Report

    Report Number
    9615754-2019-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PTJ
    UDI-DI
    03573026464370
    PMA / PMN Number
    K162385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A CUSTOMER REPORT OF A FALSE NEGATIVE RESULT FOR A KLEBSIELLA PNEUMONIA ISOLATE IN ASSOCIATION WITH THE API® RAPIDEC® CARBA NP PRODUCT. THE CUSTOMER SUBMITTED THE STRAIN FOR THE INVESTIGATION. 1- RETAINED SAMPLE ANALYSIS. THE CONFORMITY OF LOT 1005739620 AND AN INTERNAL REFERENCE LOT 1006179470 USED FOR THE INVESTIGATION WAS CONFIRMED WITH TWO QC STRAINS TESTED FOR THE RELEASE OF THIS REFERENCE: KLEBSIELLA PNEUMONIAE ATCC BAA-1705 AND ATCC 700603. 2- COMPLAINTS TREND ANALYSIS. TO DATE, NONE OF THE INVESTIGATIONS CARRIED OUT HAVE HIGHLIGHTED ANY PERFORMANCE PROBLEM ON THE RAPIDEC CARBA GALLERY. FALSE POSITIVE OR FALSE NEGATIVE RESULTS OBTAINED BY CUSTOMERS HAVE NEVER BEEN REPRODUCED INTERNALLY. 3- RETURNED STRAIN ANALYSIS. IDENTIFICATION OF THE RETURNED CUSTOMER STRAIN WAS CONFIRMED AS KLEBSIELLA PNEUMONIAE WITH VITEK® MS. THE CUSTOMER STRAIN WAS TESTED ON TWO RETAINED LOTS OF RAPIDEC CARBA NP STRIPS: CUSTOMER LOT 1005739620 AND REFERENCE LOT 1006179470. THE NEGATIVE CUSTOMER RESULT WAS REPRODUCED ON BOTH LOTS. 4- COMPLEMENTARY STUDY. TO CHARACTERIZE THE STRAIN, WHOLE GENOME SEQUENCING WAS DONE TO DETERMINE IF THE STRAIN IS AN OXA48 OR AN OXA48 VARIANT AND IF SO, WHICH ONE. BROTH MICRO-DILUTION (BMD) WAS PERFORMED TO DETERMINE THE REFERENCE MIC TO THE THREE MOST COMMON CARBAPENEMS : IMIPENEM (IPM), ERTAPENEM (ETP) AND MEROPENEM (MEP). THE RESULTS OF THE WHOLE GENOME SEQUENCING ARE: PRESENCE OF GENES TEM-1, OXA-232, "TRUNCATED" CTX-M, SHV (INCLUDING ONE CODING FOR AN ESBL) (ASSAY LBMSC-AST-103): PRESENCE OF AN OXA-48 VARIANT (OXA-232). THE STRAIN IS RESISTANT TO THE THREE CARBAPENEM ANTIBIOTICS. REF IPM MIC = 8 MG/L R. REF MEP MIC = 32 MG/L R. REF ETP MIC > 16 MG/ L R. 5- CONCLUSION. THE IDENTIFICATION OF THE STRAIN RECEIVED WAS CONFIRMED AS KLEBSIELLA PNEUMONIAE BY VITEK MS. THE CUSTOMER RESULT WAS REPRODUCED INTERNALLY. THE CUSTOMER'S STRAIN IS A CARBAPENAMASE PRODUCER. IT IS AN OXA-48 VARIANT PRODUCING BACTERIA (OXA-232). THE STRAIN EXPRESSED ITS RESISTANCE TO THE THREE MOST COMMON CARBAPENEMS (IMIPENEM, MEROPENEM, ERTAPENEM). THE CARBAPENEMASE OF THE OXACILLINASE CLASS ARE KNOWN TO BE SLIGHTLY EXCRETED AND THEN DIFFICULT TO BE DETECTED BY THE PHENOTYPICAL METHODS. FURTHERMORE, DURING THE PERFORMANCE EVALUATION OF RAPIDEC CARBA NP, IT WAS NOT POSSIBLE TO COLLECT A LARGE NUMBER OF OXA-48 VARIANT STRAINS. TWO LIMITATIONS HAVE BEEN INCLUDED IN THE PACKAGE INSERT CAUTIONING THAT THE RAPIDEC CARBA NP HAS NOT BEEN EVALUATED ON THOSE OXA-48 VARIANTS AS REPORTED BELOW: THE DETECTION OF OXA VARIANTS OTHER THAN OXA-48 HAS NOT BEEN EVALUATED SUFFICIENTLY IN THE STUDY. THE PERFORMANCE OF THE RAPIDEC® CARBA NP TEST WHEN TESTING ENTEROBACTERIACEAE AND PSEUDOMONAS AERUGINOSA CONTAINING OXA-181, OXA-232, SME, GIM, SPM, AND IMI CARBAPENEMASE ENZYMES HAS NOT BEEN ESTABLISHED DUE TO THE LOW NUMBER OF POSITIVE ISOLATES AVAILABLE USING THE COMPOSITE REFERENCE METHOD.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMÉRIEUX TO REPORT A FALSE NEGATIVE RESULT FOR A KLEBSIELLA PNEUMONIA ISOLATE IN ASSOCIATION WITH THE RAPIDEC® CARBA NP PRODUCT. THE CUSTOMER STATED THEY TESTED THE KLEBSIELLA PNEUMONIA ISOLATE TWICE WITH MICROSCAN; THE RESULT INDICATED A POSSIBLE CARBAPENEM RESISTANT ENTEROBACTERIACEAE (CRE). TESTING WITH RAPIDEC CARBA NP PROVIDED A "NEGATIVE" RESULT. THE RESULT PROVIDED TO THE PHYSICIAN WAS "CRE WITH CARBA NP TEST NEGATIVE". THE PATIENT ISOLATE WAS SENT TO AN EXTERNAL LABORATORY FOR FURTHER TESTING BECAUSE THE CUSTOMER REMAINED SUSPICIOUS OF CRE. PCR TESTING WAS PERFORMED = POSITIVE FOR OXA 48 CARBAPENEMASE. THE REPORT TO PHYSICIAN WAS MODIFIED THAT PCR TESTING WAS CRE POSITIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX REQUESTED STRAIN SUBMITTAL FROM THE CUSTOMER. BIOMÉRIEUX INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98609 API® RAPIDEC® CARBA NP RAPIDEC® CARBA NP PTJ BIOMERIEUX, SA 1005739620 03573026464370

    Patients

    Seq Age Sex Outcome Treatment
    1