BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® SN CULTURE BOTTLE

    MDR report key: 5070256 · Received September 11, 2015

    Report

    Report Number
    3002769706-2015-00084
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    September 1, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K021123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT FOR A (B)(6) RESULT ON ONE BACT/ALERT® SN PART NUMBER (P/N (B)(4)) BOTTLE. THE CUSTOMER COMPLAINT WAS RECEIVED FOR A BACT/ALERT®® SN BOTTLE FLAGGING (B)(6) FOR A KNOWN (B)(6) QC SAMPLE CONTAINING BACTEROIDES FRAGILIS AT 5-DAYS, LOT NUMBER 3043471. A BATCH RECORD REVIEW FOR LOT 3043471 WAS PERFORMED. THERE WERE NO UNUSUAL INCIDENTS OR NON-CONFORMANCES ASSOCIATED WITH THE PRODUCTION OF THIS LOT. BACTEROIDES FRAGILIS IS ON THE FINAL QA LOT RELEASE TEST PANEL. THERE WERE NO OOS RESULTS FOR BACT/ALERT® SN PART NUMBER (P/N (B)(4)), LOT NUMBER 3043470. A REVIEW OF THE PACKAGE INSERT FOR THE BACT/ALERT® SN CULTURE BOTTLE WAS PERFORMED. UNDER THE REAGENTS SECTION IT READS "IT IS POSSIBLE THAT CERTAIN RARE, FASTIDIOUS MICROORGANISMS WILL NOT GROW OR MAY GROW SLOWLY IN THE BACT/ALERT® SN CULTURE BOTTLE GROWTH MEDIUM. IF RARE, FASTIDIOUS ORGANISMS REQUIRING SPECIALIZED MEDIA AND CULTURE CONDITIONS ARE SUSPECTED, ALTERNATIVE METHODS OR EXTENDED INCUBATION TIME, SHOULD BE CONSIDERED FOR RECOVERY". BACTEROIDES FRAGILIS IS A FASTIDIOUS ANAEROBIC ORGANISM, AN ORGANISM THAT HAS A COMPLEX NUTRITIONAL REQUIREMENT THAT DOES NOT REQUIRE OXYGEN FOR GROWTH, AND MAY REACT (B)(4) OR EVEN DIE IF OXYGEN IS PRESENT. IT IS A VERY DIFFICULT ORGANISM TO WORK WITH, AND THE CUSTOMER MAY HAVE INTRODUCED ENOUGH OXYGEN INTO THE SAMPLE TO HAVE AN ADVERSE EFFECT ON THE VIABILITY OF THE ORGANISM. ADDITIONALLY, THE LABORATORY PROCEDURE STATES "(B)(6) CULTURES MAY BE CHECKED BY SMEAR AND/OR SUBCULTURE AT SOME POINT PRIOR TO DISCARDING AS (B)(6)." ADDITIONALLY, A NOTE IS INCLUDED WITHIN THE PACKAGE INSERT WHICH STATES, "THE (B)(6) STATUS COULD BE DUE TO UNDER-INOCULATION OF THE BOTTLE, NO ORGANISMS PRESENT IN THE INOCULUM, THE NUMBER OF ORGANISMS WERE TOO SMALL FOR DETECTION, OR A CULTURE BOTTLE/MEDIUM THAT DOES NOT SUPPORT THE GROWTH OF THE ORGANISM." A REVIEW OF THE DATA FROM THE INSTRUMENT BACK-UP WAS PERFORMED. THE REVIEW REVEALED THAT THE CULTURE BOTTLE IN QUESTION SEEMED TO BE A (B)(6) BOTTLE BASED ON ITS GROWTH CURVE. IT WAS NOT DECLARED POSITIVE BECAUSE IT ONLY CULTURED FOR 5 DAYS. BASED ON THE ANALYSIS, IT LIKELY WOULD HAVE BEEN DECLARED POSITIVE IF THE TESTING TIME WAS EXTENDED. A TREND REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM (B)(6) 2015 TO (B)(6) 2015. THERE WERE NO COMPLAINTS DETERMINED TO BE RELATED. IT HAS BEEN DETERMINED THAT THERE IS NOT AN ADVERSE TREND FOR THIS ISSUE. THE EXACT ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. A PROBABLE ROOT CAUSE IS UNKNOWN, THERE IS INSUFFICIENT INFORMATION FROM THE CUSTOMER TO DETERMINE A POTENTIAL CAUSE. CONTRIBUTORY FACTORS COULD BE INSUFFICIENT DILUTION, INHIBITORY EFFECTS OF THIOGLYCOLLATE, OXYGENATION AND LACK OF BLOOD TO THE SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER CONTACTED BIOMERIEUX TO REPORT A DISCREPANT RESULT ASSOCIATED WITH A QC SAMPLE WITH THE BACT/ALERT SN CULTURE BOTTLE. THE CUSTOMER INOCULATED THE CULTURE BOTTLE WITH A KNOWN SAMPLE OF BACTEROIDES FRAGILIS AS PART OF THEIR QUALITY CONTROL PROCEDURE. THE CULTURE BOTTLE HAD A FINAL DETERMINATION OF NEGATIVE; HOWEVER, UPON SUBCULTURE, THE RESULT WAS POSITIVE. AN INTERNAL INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO DETERMINE THE CAUSE OF THIS DISCREPANT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603234 BACT/ALERT® SN CULTURE BOTTLE BACT/ALERT® SN CULTURE BOTTLE MDB BIOMERIEUX, INC 3043471

    Patients

    Seq Age Sex Outcome Treatment
    1