BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID SALMONELLA AGAR

    MDR report key: 4957213 · Received July 31, 2015

    Report

    Report Number
    3002769706-2015-00062
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    June 29, 2015
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JWX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED USING THE CHROMID TM SALMONELLA RETAINED SAMPLES OF THE CUSTOMER BATCH (1003998840) IN COMPARISON WITH A RANDOM BATCH OF CHROMID SALMONELLA AS REFERENCE. SAMPLE STRAINS WERE THE SAME AS THOSE USED DURING RELEASE TESTS. GOOD GROWTH WAS OBSERVED FOR ALL QUALITY CONTROL SALMONELLA STRAINS ON THE CUSTOMER BATCH (1003998840) WITH CHARACTERISTIC PALE PINK-MAUVE COLONIES AFTER 24H OF INCUBATION, AND DARK MAUVE COLONIES AFTER 48H OF INCUBATION. THE SAME RESULTS WERE OBSERVED FOR THE REFERENCE BATCH. IN ADDITION, TESTING WAS PERFORMED WITH THE STRAIN SUBMITTED BY THE CUSTOMER ON THE CUSTOMER BATCH (1003998840) AND ON A RANDOM BATCH OF CHROMID SALMONELLA AS REFERENCE. THE SAME RESULTS WERE OBSERVED FOR THE TWO BATCHES. GOOD GROWTH WAS OBSERVED FOR THE CUSTOMER'S STRAIN, WITH UNCOLORED COLONIES AFTER 24 HOURS OF INCUBATION AT 33-37°C AND PALE MAUVE COLONIES AFTER 48 HOURS OF INCUBATION. IT WAS OBSERVED THAT THE CUSTOMER'S STRAIN PRESENTS A SLOW GROWTH WHATEVER THE CHROMID SALMONELLA BATCH USED, AND THEREFORE THE REPORTED ISSUE IS NOT RELATED TO ANY DEFECT WITH THE PERFORMANCE OF THE CHROMID SALMONELLA AGAR REF 43621, LOT 1003998840. AS INDICATED IN THE PACKAGE INSERT OF THIS MEDIUM, SOME SALMONELLA SEROVARS MAY PRODUCE A WEAK COLORATION OR BE SLOW TO PRODUCE A COLORATION. THE REVIEW OF COMPLAINT RECORDS INDICATES THAT NO OTHER COMPLAINT HAS BEEN REGISTERED AGAINST THIS BATCH NUMBER. DURING THE REVIEW OF THE MANUFACTURING AND QC BATCH RECORDS, WE HAVE IDENTIFIED THE FOLLOWING INFORMATION: THIS BATCH (NUMBER 1003998840, EXPIRY DATE: 2015-09-30) WAS MANUFACTURED 13MAY2015. NO DISCREPANCIES WERE DETECTED DURING THE MANUFACTURING OF THIS BATCH. FOR THE RELEASE OF THE BATCH AFTER ITS MANUFACTURING, THE RESULTS OF THE MICROBIOLOGICAL QUALITY CONTROL ARE IN ACCORDANCE WITH SPECIFICATIONS AS INDICATED IN THE QUALITY CERTIFICATE.

    Description of Event or Problem · 1

    A CLINICAL CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT THE OBSERVATION OF WHITE COLONIES ON CHROMID[TM] SALMONELLA AGAR (REF. (B)(4), LOT 1003998840) WHEN THE CUSTOMER WAS EXPECTING TO SEE THE TYPICAL PINK/MAUVE COLONIES INDICATIVE OF A POSITIVE SAMPLE. THE CUSTOMER CLASSIFIED THIS AS A FALSE NEGATIVE RESULT. THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR EVIDENCE OF PATIENT DEATH OR SERIOUS INJURY AS A RESULT OF THE EVENT. THE REFERENCED PRODUCT IS FOR SALE IN THE UNITED STATES FOR INDUSTRY USE ONLY, AND IS NOT USED TO TEST PATIENT SAMPLES; HOWEVER, WERE THE EVENT TO RECUR WHILE TESTING PRODUCTS FOR HUMAN CONSUMPTION, CONTAMINATED PRODUCT COULD BE INTRODUCED INTO MARKET. ADDITIONALLY, SIMILAR CHROMID AGAR PRODUCTS ARE SOLD IN THE UNITED STATES FOR CLINICAL USE. BIOMERIEUX HAS REQUESTED THE PATIENT ISOLATE FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502032 CHROMID SALMONELLA AGAR CHROMID SALMONELLA AGAR JWX BIOMÉRIEUX SA 1003998840

    Patients

    Seq Age Sex Outcome Treatment
    1