BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDEC CARBA NP

    MDR report key: 10906452 · Received November 25, 2020

    Report

    Report Number
    9615754-2020-00184
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    May 21, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PTJ
    PMA / PMN Number
    K162385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION WAS INITIATED FOLLOWING PMS 2020 ARTICLE 130246665, ¿EVALUATION OF TWO COMMERCIAL METHODS FOR RAPID DETECTION OF THE CARBAPENEMASE-PRODUCING KLEBSIELLA PNEUMONIAE¿ THIS ARTICLE REPORTS THE NON-DETECTION OF K. PNEUMONIAE CARBAPENEMASE PRODUCERS (FALSE NEGATIVE RESULTS) ON RAPIDEC CARBA NP PRODUCT. THE INSTRUCTIONS FOR USE (IFU) ARE SAID TO BE FOLLOWED, BUT THE ARTICLE IS NOT DETAILED ENOUGH TO CHECK IT FORMALLY. THE ARTICLE PRESENTS THE COMPARISON OF TWO (2) COMMERCIAL METHODS: RAPIDEC CARBA NP / NG-TEST CARBA 5 ON THE DETECTION OF 194 CARBAPENEMASE K. PNEUMONIAE PRODUCERS AND 30 NON-CARBAPANEMASE. IT STATES THAT 35 OXA-48 LIKE STRAINS ARE NOT DETECTED BY RAPIDEC CARBA OVER 85. THIS LED TO A SENSITIVITY EQUAL TO 81.9%; UNDER THE EXPECTED LEVEL OF PERFORMANCE OF THE TEST (97.8% FOLLOWING THE EUROPEAN EXTERNAL VALIDATION SEE IFU). THE AUTHORS WERE CONTACTED TO INVESTIGATE THIS NON DETECTION. THE SUBMITTAL OF THE STRAINS WERE REQUESTED TO FIRST REPRODUCE THE RAPIDEC CARBA NP TESTING AND OBSERVE THE COLOR OF THE WELL "D" AND "E" ON THOSE 35 OXA-48 LIKE STRAINS. ALSO THE WHOLE GENOME SEQUENCING OF THOSE STRAINS WOULD HAVE BEEN NEEDED TO DEFINE IF THEY WERE OXA-48 OR VARIANTS OF OXA-48. WE ALSO HOPED TO DETERMINE THE IMIPENEM MINIMUM INHIBITORY CONCENTRATION (MIC) ON THOSE STRAINS TO DEFINE IF THE EXPRESSION OF THE CARBAPENEMASE WAS ENOUGH TO ALLOW A PHENOTYPICAL DETECTION. THE AUTHORS ANSWERED ON FEB 2021 THAT THE STRAINS WOULD NOT BE SUBMITTED. WITHOUT THE STRAINS, IT IS IMPOSSIBLE TO INVESTIGATE FURTHER. THERE IS NO FORMAL EVIDENCE THAT THE RAPIDEC CARBA NP IS OUT OF ITS EXPECTED LEVEL OF PERFORMANCE. ON 30 APR 2021, THE INVESTIGATOR REVIEWED COMPLAINT DATABASE RECORDS FOR REPORTS AGAINST RAPIDEC CARBA NP PRODUCT SINCE 2018. NO TREND RELATED TO PERFORMANCE ISSUE, AND PARTICULARLY RELATED TO FALSE NEGATIVE RESULTS, WAS OBSERVED. HAD THE STRAINS IN QUESTION BEEN AVAILABLE FOR TESTING, THE INVESTIGATION COULD HAVE RULED OUT OR CONFIRMED: - THE STRAINS NOT DETECTED IN RAPIDEC CARBA NP ARE OXA-48 OR OXA-48 LIKE ENTEROBACTERALES (VARIANTS). THESE LATTER STRAINS ARE KNOWN TO EXHIBIT LOW EXCRETION OF CARBAPENEMASE AND THEREFORE ARE DIFFICULT TO DETECT BY PHENOTYPIC METHOD. HOWEVER, DURING THE PERFORMANCE STUDIES OF RAPIDEC CARBA NP, THIS TYPE OF STRAIN (OXA-48 LIKE) WAS TESTED AND NO PERFORMANCE PROBLEM WAS DETECTED INTERNALLY. INDEED IN THE STUDIES PERFORMED IN EUROPE 275 STRAINS WERE TESTED AMONG THEM 136 WERE CHARACTERIZED AS CARBAPENEMASE BY PCR AND 27 OXA48, 5 OXA23, 4 OXA24,1 OXA58, 1 NDM+OXA48 AND 1 OXA23+OXA51 WERE TESTED. AMONG THOSE 39 OXA-48 AND VARIANT, THREE (3) STRAINS WERE NOT DETECTED (1 K. PNEUMONIAE OXA-48 AND 2 A. BAUMANII OXA-23 AND OXA-24). - BIAS IN THE PROTOCOL IMPLEMENTED DURING THE STUDY, - INOCULUM NOT LOADED ENOUGH - WRONG INTERPRETATION OF COLORS (CASE OF RED-ORANGE MUST BE READ AS POSITIVE)) CONCLUSION WITHOUT THE STRAINS IN QUESTION; BIOMÉRIEUX CANNOT INVESTIGATE THIS REPORT FURTHER. NO TREND OBSERVED IN THE COMPLAINTS SEARCH RELATED TO FALSE NEGATIVE RESULTS OBTAINED WITH PRODUCT RAPIDEC CARBA NP. THERE IS NO FORMAL EVIDENCE THAT THE RAPIDEC CARBA NP IS OUT OF ITS EXPECTED LEVEL OF PERFORMANCE THE INVESTIGATION DID NOT HIGHLIGHT PERFORMANCE ISSUE FOR RAPIDEC CARBA NP, THUS NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED.

    Description of Event or Problem · 1

    AN INTERNAL COMPLAINT WAS INITIATED FOLLOWING A REVIEW OF A SCIENTIFIC PUBLICATION ENTITLED, "EVALUATION OF TWO COMMERCIAL METHODS FOR RAPID DETECTION OF THE CARBAPENEMASE-PRODUCING KLEBSIELLA PNEUMONIAE" BY GELMEZ G, ET AL. THIS PUBLICATION NOTED FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE RAPIDEC® CARBA NP (10) (REF 415418). A TOTAL OF 224 NON-DUPLICATE KLEBSIELLA PNEUMONIAE ISOLATES WERE USED IN THIS STUDY TO COMPARE THE PERFORMANCE OF THE RAPIDEC® CARBA NP TO THE NG-TEST CARBA-5 (NG BIOTECH). THE STRAINS WERE COLLECTED FROM VARIOUS CLINICAL SAMPLES OBTAINED BETWEEN JANUARY 2015 AND DECEMBER 2018 AT MARMARA UNIVERSITY HOSPITAL IN ISTANBUL, TURKEY. ALL ISOLATES WERE PREVIOUSLY CHARACTERIZED BY POLYMERASE CHAIN REACTION (PCR) TO DETERMINE WHICH CARBAPENEMASE PRODUCING GENES WERE PRESENT IN EACH ORGANISM. 85 ISOLATES WERE IDENTIFIED BY PCR TO BE OXA-48-LIKE CARBAPENEMASE PRODUCERS. OF THESE 85 ISOLATES, THE RAPIDEC® CARBA NP CORRECTLY DETECTED 50 ISOLATES AS POSITIVE FOR CARBAPENEMASE. FALSE NEGATIVE RESULTS WERE INTERPRETED FOR THE OTHER 35 ISOLATES. THERE IS NO INDICATION OR REPORT IN THE PUBLICATION THAT ANY RESULTS OBTAINED DURING THE STUDY WERE USED FOR DIAGNOSIS AND/OR TREATMENT DECISIONS. THERE IS NO INDICATION OR REPORT IN THE PUBLICATION THAT THE FALSE NEGATIVE RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371497 RAPIDEC CARBA NP RAPIDEC® CARBA NP PTJ BIOMERIEUX, SA

    Patients

    Seq Age Sex Outcome Treatment
    1