BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST® BENZYLPENICILLIN PG 32 WW F100

    MDR report key: 8880345 · Received August 9, 2019

    Report

    Report Number
    9615754-2019-00058
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JWY
    PMA / PMN Number
    K981135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BIOMERIEUX PERFORMED AN INVESTIGATION IN RESPONSE TO DISCREPANT RESULTS OBTAINED BETWEEN ETEST® BENZYLPENICILIN PG32. STRIPS (REFERENCE 502618, LOT NUMBER 1006836110) AND BROTH MICRO DILUTION (BMD) REFERENCE METHOD FOR THIRTEEN (13). STREPTOCOCCUS PNEUMONIAE PATIENT STRAINS. BIOMERIEUX REVIEWED THE CUSTOMER REPORTS FOR THE THIRTEEN ISOLATES AND DETERMINED EIGHT (8) OF THE CUSTOMER STRAINS ARE IN AGREEMENT (WITHIN ONE DOUBLING DILUTION) WITH THE BMD REFERENCE METHOD. FOUR OF THE FIVE CUSTOMER ISOLATES WERE WHICH WERE NOT WITHIN ONE DOUBLING DILUTION WERE SUBMITTED TO BIOMERIEUX FOR INVESTIGATION AND CONFIRMED TO BE STREPTOCOCCUS PNEUMONIAE VIA VITEK® MS. BIOMERIUEX'S INVESTIGATION INCLUDED THE FOLLOWING: TESTING OF CUSTOMER LOT 1006836110 AND INTERNAL REFERENCE LOT 1007477180 AGAINST ATCC® QUALITY CONTROL STRAINS. TESTING THE FOUR SUBMITTED CUSTOMER ISOLATES AGAINST THE BMD REFERENCE METHOD. TESTING THE SUBMITTED ISOLATES USING CUSTOMER LOT 1006836110 AND INTERNAL REFERENCE LOT 1007477180 USING BOTH THE EUCAST AND CLSI BREAKPOINTS 2019. ALL ATCC® STRAINS OBTAINED CONFORMING RESULTS FOR BOTH THE ETEST CUSTOMER LOT AND THE REFERENCE LOT. THE BMD (CLSI) RESULTS: ISOLATE 1 PG MINIMUM INHIBITORY CONCENTRATION (MIC) = 2 MG/L CATEGORIZED AS SUSCEPTIBLE; ISOLATE 2 PG MIC = 1 MG/L CATEGORIZED AS SUSCEPTIBLE; ISOLATE 3 PG MIC = 2 MG/L CATEGORIZED AS SUSCEPTIBLE; ISOLATE 4 PG MIC = 4 MG/L CATEGORIZED AS INTERMEDIATE. THE BMD (EUCAST) RESULTS: ISOLATE 1 PG MIC = 2 MG/L CATEGORIZED AS INTERMEDIATE; ISOLATE 2 PG MIC = 1 MG/L CATEGORIZED AS INTERMEDIATE; ISOLATE 3 PG MIC = 2 MG/L CATEGORIZED AS INTERMEDIATE; ISOLATE 4 PG MIC = 4 MG/L CATEGORIZED AS RESISTANT. MIC RESULTS WERE EQUIVALENT FOR THE FOUR STRAINS BETWEEN BMD EUCAST AND BMD CLSI. THE CATEGORIZATION VARIES DUE TO THE DIFFERENCE IN THE BREAKPOINTS BETWEEN BOTH GUIDELINES. THE FOUR STRAINS RETURNED WERE TESTED USING THE ETEST® PG 32 CUSTOMER LOT (CL) 1006836110 AND REFERENCE LOT (RL) 1007477180 PLATED ONTO MUELLER HINTON AGAR + 5% SANG (CLSI GUIDELINES) AND MUELLER HINTON AGAR WITH 5% HORSE BLOOD + 20 MG/L B-NAD (EUCAST GUIDELINES). MIC RESULTS OBTAINED ON MUELLER HINTON AGAR + 5% SANG (CLSI GUIDELINES): ISOLATE 1 ETEST PG MIC = 1 MG/L (CL) AND 2 MG/L (RL) CATEGORIZED AS SUSCEPTIBLE; ISOLATE 2 ETEST PG MIC = 1 MG/L (CL & RL) CATEGORIZED AS SUSCEPTIBLE; ISOLATE 3 ETEST PG MIC = 0.5 MG/L (CL) AND 1 MG/L (RL) CATEGORIZED AS SUSCEPTIBLE; ISOLATE 4 ETEST PG MIC = 4 MG/L (CL & RL) CATEGORIZED AS INTERMEDIATE. MIC RESULTS OBTAINED ON MUELLER HINTON AGAR WITH 5% HORSE BLOOD + 20 MG/L B-NAD (EUCAST GUIDELINES): ISOLATE 1 ETEST PG MIC = 1 MG/L (CL & RL) CATEGORIZED AS INTERMEDIATE. ISOLATE 2 ETEST PG MIC = 1 MG/L (CL & RL) CATEGORIZED AS INTERMEDIATE. ISOLATE 3 ETEST PG MIC = 1 MG/L (CL & RL) CATEGORIZED AS INTERMEDIATE. ISOLATE 4 ETEST PG MIC = 2 MG/L (CL & RL) CATEGORIZED AS INTERMEDIATE. THE ETEST PG32 RESULTS OF THE ISOLATES 1, 2 AND 3 ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE RESULTS WITHOUT CATEGORY ERROR. THE ETEST PG32 RESULTS OF THE ISOLATE 4 ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE METHOD BUT LEAD TO MINOR CATEGORY ERROR. THE ISOLATES 1, 3, 4 CAN BE CONSIDERED BORDERLINE STRAINS FOR BENZYLPENICILLIN, AS THE REFERENCE MICS ARE ON THE BREAKPOINTS. THE INTERPRETATION CAN SHIFT FROM "SUSCEPTIBLE TO INTERMEDIATE" (FOR ISOLATE 1 AND ISOLATE 3), AND "INTERMEDIATE TO RESISTANT" (FOR ISOLATE 4) WITHIN ONE DOUBLING DILUTION.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF POTENTIAL DISCREPANT RESULTS FOR BENZYLPENICILLIN WHEN TESTING 14 STREPTOCOCCUS PNEUMONIAE STRAINS FROM PATIENT ISOLATES ON ETEST® BENZYLPENICILLIN PG 32 (REF. 502618), LOT. 1006836110, WHEN COMPARED TO THE REFERENCE LABORATORY RESULTS. IT SHOULD BE NOTED THAT THE CUSTOMER USED HOMEMADE MEDIA FOR TESTING WITH ETEST®. THE REFERENCE LABORATORY USED PREPARED PLATES FOR BMD. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE COMPARISON OF RESULTS OBTAINED WITH THE IMPACTED LOT OF ETEST® TO THE REFERENCE MIC RESULTS (OBTAINED WITH BMD) ARE SUMMARIZED AS FOLLOWS: FOR EIGHT (8) STRAINS, MIC VALUES OBTAINED WITH THE IMPACTED LOT OF ETEST® ARE IN AGREEMENT WITH THE REFERENCE MIC RESULTS. FOR THREE (3) STRAINS, THERE ARE DISCREPANT RESULTS BETWEEN ETEST® AND THE BMD METHOD BUT WITHOUT ANY ERROR OF CATEGORY (INTERMEDIATE). FOR ONE (1) STRAIN, THE MIC VALUE WITH ETEST® IS IN AGREEMENT WITH THE REFERENCE MIC RESULT, BUT ON THE HIGH CRITICAL CONCENTRATION THAT LED TO A MINOR ERROR OF CATEGORY (INTERMEDIATE INSTEAD OF RESISTANT). FOR TWO (2) STRAINS, THERE ARE DISCREPANT RESULTS BETWEEN ETEST® AND THE BMD METHOD WITH A MINOR ERROR OF CATEGORY (INTERMEDIATE INSTEAD OF RESISTANT) DUE TO THE FACT THAT THE MIC VALUES FOR THOSE STRAINS ARE ON THE HIGH BREAKPOINT. IN SUMMARY, 11 OF THE 14 STRAINS HAD NO CHANGE IN THE SUSCEPTIBILITY CATEGORY. THREE (3) OF THE 14 STRAINS CATEGORY CALL WAS INTERMEDIATE INSTEAD OF RESISTANT. THE CUSTOMER DID NOT REPORT ANY KNOWN INCORRECT TREATMENT OR PATIENT INJURY DUE TO THESE DISCREPANT RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674977 ETEST® BENZYLPENICILLIN PG 32 WW F100 ETEST® BENZYLPENICILLIN JWY BIOMERIEUX SA 1006836110

    Patients

    Seq Age Sex Outcome Treatment
    1