BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID STREPTO B AGAR

    MDR report key: 6993848 · Received November 1, 2017

    Report

    Report Number
    3002769706-2017-00327
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Report Date
    March 12, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PQZ
    PMA / PMN Number
    K163042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS WHEN TESTING A QUALITY CONTROL SAMPLE USING CHROMID¿ STREPTO B AGAR (REFERENCE (B)(4)). AN INVESTIGATION WAS PERFORMED. INCRIMINATED PLATES WERE NOT SUBMITTED BY THE CUSTOMER FOR EVALUATION. THIS INVESTIGATION CONSISTED OF A REVIEW OF QUALITY RECORDS FOR IMPACTED LOT NUMBERS 1005910980 AND 1005925100. THE QUALITY CONTROL RECORDS FOR BOTH LOTS SHOWED CONFORMANCE WITH SPECIFICATIONS, IN TERM OF FERTILITY AND SELECTIVITY , AS INDICATED IN THE QUALITY CERTIFICATE. NO DISCREPANCIES WERE DETECTED DURING THE MANUFACTURING OF THE TWO LOTS. BACTERIOLOGICAL ANALYSIS WAS PERFORMED ON THE CHROMID¿ STREPTO B AGAR IMPACTED LOTS (1005910980 AND 1005925100) AND A REFERENCE LOT (1005941130), FOLLOWING THE QC METHOD WITH THE QC STRAINS. IN PARALLEL, A BATCH OF TRYPCASE SOY AGAR (REF. (B)(4), 1005904120) WAS USED FOR CONTROL. THE RESULTS WERE: GOOD GROWTH OF PINK TO RED COLONIES FOR STRAINS, STREPTOCOCCUS AGALACTIAE ATCC 12836 AND NCTC 8190 IN 24 HOURS. TOTAL INHIBITION FOR ESCHERICHIA COLI ATCC 25922 AND STAPHYLOCOCCUS AUREUS ATCC 6538 IN 24 HOURS. PARTIAL INHIBITION FOR CANDIDA ALBICANS ATCC 10231. ALL RESULTS ARE IN ACCORDANCE WITH THE EXPECTED SPECIFICATIONS. THE INVESTIGATION CONCLUDED THAT THE PERFORMANCE OF CHROMID¿ STREPTO B AGAR (REFERENCE (B)(4) LOT 1005910980 AND 1005925100) WAS WITHIN SPECIFICATIONS. THE ISSUE REPORTED BY THE CUSTOMER WAS NOT OBSERVED. WITHOUT RETURN OF CUSTOMER PLATES, IT IS NOT POSSIBLE TO CONTINUE THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT IS TO CORRECT THE FOLLOWING FIELDS: THE PRODUCT CODE SHOULD BE PQZ. INSTEAD OF 510K EXEMPT 510K # K163042 SHOULD BE USED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS WHEN TESTING A QUALITY CONTROL SAMPLE USING CHROMID¿ STREPTO B AGAR (REFERENCE 43461). THE CUSTOMER REPORTED THAT THEY REPEATED THE QUALITY CONTROL TEST USING THE SAME QUALITY CONTROL SAMPLE AND THEIR SECOND LOT OF CHROMID¿ STREPTO B AGAR REFERENCE 43461 AND HAD OBTAINED THE SAME DISCREPANT RESULT. THIS SECOND EVENT HAS BEEN RECORDED UNDER (B)(4). THE CUSTOMER STATED THAT THEY HAD INOCULATED STREP. AGALACTIAE ATCC 13813 QUALITY CONTROL SAMPLE DIRECTLY IN THE AGAR PLATES AND THAT AFTER 18-24 HOURS INCUBATION UNDER CO2, THEY HAD OBSERVED THE EXPECTED CHARACTERISTIC BACTERIAL GROWTH (RED COLONIES). THE CUSTOMER REPORTED THAT IN PARALLEL THEY HAD DIRECTLY INOCULATED IN THE SAME PLATES E. COLI ATCC 25922 AS A NEGATIVE QUALITY CONTROL SAMPLE AND THAT AFTER 18-24 HOUR INCUBATION UNDER CO2, THEY HAD OBSERVED UNEXPECTED BACTERIAL GROWTH OF RED COLONIES ON BOTH LOTS. THE CUSTOMER SAID THAT THEY HAD DISCARDED ALL THEIR INVENTORY OF THE CONCERNED PRODUCT AND THAT PATIENTS' SAMPLES' WERE NOT TESTED ON THESE TWO LOTS. THE CUSTOMER MENTIONED THAT THE ISSUE HAS BEEN OBSERVED ONLY ON THESE TWO NEW PRODUCT LOTS AND THAT THE EXPECTED NEGATIVE RESULTS WERE OBTAINED WHEN TESTING PREVIOUS LOT NUMBER OF THE CHROMID¿ STREPTO B AGAR REFERENCE 43461 WITH THE SAME E. COLI ATCC 25922 QUALITY CONTROL SAMPLE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER TO BIOMÉRIEUX THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE QUALITY CONTROL SAMPLE RESULTS ARE NOT DIRECTLY ASSOCIATED WITH ANY PATIENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774044 CHROMID STREPTO B AGAR CHROMID¿ STREPTO B AGAR PQZ BIOMERIEUX SA 1005925100

    Patients

    Seq Age Sex Outcome Treatment
    1