BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID CARBA SMART AGAR

    MDR report key: 5623945 · Received May 2, 2016

    Report

    Report Number
    3002769706-2016-00078
    Event Type
    Malfunction
    Date Received
    May 2, 2016
    Report Date
    April 15, 2016
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH CHROMID® CARBA SMART AGAR (REFERENCE 414685) INVOLVING A QUALITY CONTROL SAMPLE OF E. COLI WHERE THE ORGANISM GREW SCANT PINK ON THE CARBA SIDE AND THERE WAS NO GROWTH ON THE OXA SIDE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: COMPLAINT HISTORY REVIEW REVEALED NO ADDITIONAL COMPLAINTS INVOLVING THE CUSTOMER'S LOT. BIOMÉRIEUX REQUESTED THE STRAIN FROM THE CUSTOMER; HOWEVER, THE CUSTOMER'S STRAIN WAS NOT RECEIVED. A RETENTION SAMPLE OF THE CUSTOMER'S LOT (1004671720) IN PARALLEL WITH TWO LOTS OF CHROMID® CARBA SMART AGAR (1004737760/1004760850) AND A LOT OF COS WERE TESTED. TESTING STRAINS INCLUDED ESCHERICHIA COLI2 (REF (B)(4)), PROTEUS RETTGERI2 (REF (B)(4)), KLEBSIELLA PNEUMONIAE2 (REF (B)(4)) NCTC (B)(4), ENTEROBACTER CLOACAE (REF (B)(4)), KLEBSIELLA PNEUMONIAE2 (REF (B)(4)), KLEBSIELLA PNEUMONIAE2 (REF (B)(4)), AND KLEBSIELLA PNEUMONIAE2 (REF (B)(4)). RESULTS- AFTER INCUBATION UNDER AEROBIC CONDITIONS AT 33-37° C FOR 18-24 HOURS, PRODUCT PERFORMANCE WAS WITHIN SPECIFICATIONS REGARDING FERTILITY AND COLOR INTENSITY. THERE WERE NO DIFFERENCES BETWEEN LOTS DETECTED. ALL POSITIVE STRAINS WERE RECOVERED AND NO FALSE NEGATIVE REACTIONS WERE DETECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A DISCREPANT RESULT ASSOCIATED WITH CHROMID CARBA SMART AGAR (REFERENCE 414685). THE PLATE WAS INOCULATED WITH A QUALITY CONTROL SAMPLE OF E. COLI INDICATED AS NOT BEING ATCC STRAIN, BUT FROM A MICROBIOLOGIST'S CARBAPENEMASE COLLECTION THAT WAS ISOLATED IN TUNISIA IN 2012 AND PRODUCES TEM, CTX-M-14 AND OXA-244 ENZYMES. THE CUSTOMER INDICATED THE ORGANISM IS SUBBED FROM FROZEN EACH TIME QC IS SET UP. THE CUSTOMER REPORTED THE ORGANISM GREW SCANT PINK ON THE CARBA SIDE AND THERE WAS NO GROWTH ON THE OXA SIDE WHEREAS, THERE SHOULD HAVE ONLY BEEN GROWTH ON THE OXA SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279259 CHROMID CARBA SMART AGAR CHROMID CARBA SMART AGAR JSI BIOMÉRIEUX SA 1004671720

    Patients

    Seq Age Sex Outcome Treatment
    1