BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    API® 20 A 25STRIPS+25MEDIA

    MDR report key: 11873537 · Received May 24, 2021

    Report

    Report Number
    9615754-2021-00168
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    JSP
    UDI-DI
    03573026048150
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION RESULT IN ASSOCIATION WITH THE API® 20 A (REF. (B)(4), LOT 1008247410) WHEN TESTING A CAP SURVEY STRAIN. INVESTIGATION: REVIEW OF THE COMPLAINTS DATABASE REVEALED NO OTHER COMPLAINTS RELATED TO THE SAME ISSUE WITH THE CUSTOMER¿S LOT NUMBER. TESTING: A RETAINED SAMPLE FROM THE IMPACTED LOT NUMBER (1008247410) WAS TESTED IN PARALLEL WITH ONE INTERNAL LOT NUMBER USED AS REFERENCE (1008024290). THE TESTS USED THE QC STRAINS BACTEROÏDES OVATUS ATCC® 8483¿, CLOSTRIDIUM PERFRINGENS ATCC® 13124¿ AND CLOSTRIDIUM SORDELLII ATCC® 9714¿ MENTIONED IN THE PACKAGE INSERT 07882 VERSION I. THE QC RESULTS OBTAINED FOR THE THREE STRAINS TESTED ARE IN ACCORDANCE WITH THE EXPECTED SPECIFICATIONS. THE IDENTIFICATION OF THE STRAIN RECEIVED WAS CONFIRMED IN-HOUSE WITH VITEK MS AS PREVOTELLA MELANINOGENICA. IN THE API 20 A KNOWLEDGE BASE, ONLY THREE TESTS DISCRIMINATE BETWEEN PREVOTELLA MELANINOGENICA AND PREVOTELLA BIVIA. THE CONCERNED TESTS ARE SAC, RAF AND GLY. NEGATIVE RESULTS FOR SAC AND RAF TESTS WERE OBTAINED AND THE INVESTIGATION REPRODUCED THE SAME RESULTS FOR THESE TWO TESTS. POSITIVE RESULTS FOR GLY TEST WERE OBTAINED AND THE INVESTIGATION OBTAINED A DOUBTFUL RESULT (¿?¿). THE FOLLOWING ARE MENTIONED IN THE API 20 A KNOWLEDGE BASE : SAC TEST: 0% FOR PREVOTELLA BIVIA AND 83% FOR PREVOTELLA MELANINOGENICA; RAF TEST: 0% FOR PREVOTELLA BIVIA AND 89% FOR PREVOTELLA MELANINOGENICA; GLY TEST: 80% FOR PREVOTELLA BIVIA AND 18% FOR PREVOTELLA MELANINOGENICA. THE RESULTS OBTAINED DURING THE INVESTIGATION ON THOSE THREE TESTS ARE MORE IN ACCORDANCE WITH PREVOTELLA BIVIA. SUCH RESULTS CAN NEVERTHELESS BE OBSERVED FOR SOME PREVOTELLA MELANINOGENICA STRAINS BUT THEY REMAIN IN THE MINORITY OF THIS SPECIES. THE RESULTS OF QUALITY CONTROL OBTAINED DURING OUR INVESTIGATION ON THE IMPACTED PRODUCT API® 20 A, REFERENCE (B)(4), LOT 1008247410 COMPLIED WITH SPECIFICATIONS. THE BATCH RECORDS ANALYSIS DOES NOT SHOW ANY NON-CONFORMITIES DURING MANUFACTURING AND QUALITY CONTROL PROCESSES (LOT #1008247410). THE TREND ANALYSIS OF THE COMPLAINTS DOES NOT SHOW ANY DEVIATION ON THE PRODUCT API® 20 A, REFERENCE (B)(4). CONCLUSION: THE ROOT CAUSE OF THIS CUSTOMER¿S ISSUE IS THE ATYPICAL RESULTS OBTAINED USING THE CAP SURVEY STRAIN; NEGATIVE RESULTS FOR TWO (2) DISCRIMINANT TESTS, SAC AND RAF, INSTEAD OF POSITIVE RESULTS AND POSITIVE RESULT FOR DISCRIMINANT TEST GLY INSTEAD OF NEGATIVE RESULT.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A MISIDENTIFICATION RESULT IN ASSOCIATION WITH THE API® 20 A (REF. 20300, LOT 1008247410) WHEN TESTING A CAP SURVEY STRAIN. THE CUSTOMER STATED LOT 1008247410 IDENTIFIED THE ISOLATE AS PREVOTELLA BIVIA, AND CONFIRMED THE EXPECTED RESULT FOR THE SURVEY STRAIN WAS PREVOTELLA MELANINOGENICA. THE CUSTOMER REPEATED TESTING AND THE SAME MISIDENTIFICATION RESULT WAS OBTAINED. BIOMÉRIEUX CUSTOMER SERVICE HAS REQUESTED THE CAP SURVEY STRAIN AS WELL AS CUSTOMER METHODOLOGY AND TROUBLESHOOTING INFORMATION. AS THERE IS NO PATIENT ASSOCIATED WITH THIS SURVEY STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765923 API® 20 A 25STRIPS+25MEDIA API® 20 A 25STRIPS+25MEDIA JSP BIOMÉRIEUX, SA 20300 1008247410 03573026048150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown