BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID CANDIDA

    MDR report key: 4821517 · Received June 5, 2015

    Report

    Report Number
    3002769706-2015-00037
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    April 30, 2015
    Report Date
    May 12, 2015
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT SUBMIT ISOLATE STRAINS FOR INTERNAL TESTING. THE INTERNAL INVESTIGATION WAS CONDUCTED USING CHROMID CANDIDA RETAINED SAMPLES OF THE SAME LOT AS THAT USED BY THE CUSTOMER (REF. (B)(4), LOT 1003875550), AND USING THE SAME STRAINS AS USED DURING PRODUCT RELEASE TESTING. ALL RESULTS WERE IN ACCORDANCE WITH SPECIFICATIONS: GOOD GROWTH IN 48 HOURS OF CANDIDA ALBICANS WITH CHARACTERISTIC BLUE COLONIES (ATCC 2091 AND ATCC 10231). GOOD GROWTH IN 48 HOURS OF CANDIDA TROPICALIS AND CANDIDA KEFYR WITH CHARACTERISTIC PINK COLONIES (ATCC 9968 AND ATCC 1162). INHIBITED GROWTH OF OTHER STRAINS. REVIEW OF THE ASSOCIATED MANUFACTURING BATCH RECORD CONFIRMED NO DOCUMENTED ANOMALY TO EXPLAIN THE CUSTOMER REPORT OF NO GROWTH OF CANDIDA STRAIN. THE BATCH STERILIZATION TIME AND THE RESULTS OF THE MICROBIOLOGICAL QUALITY CONTROL WERE ACCORDANCE WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. THE INVESTIGATION CONCLUDED THAT THE PERFORMANCE OF CHROMID CANDIDA REF (B)(4), LOT 1003875550 IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LACK OF GROWTH WHEN TESTING A PATIENT SAMPLE IN CONJUNCTION WITH CHROMID CANDIDA AGAR ((B)(4) - LOT 1003875550 EXPIRY 29-JUN-2015) WHEREAS MICROSCOPIC EXAMINATION OF THE CONCERNED SPECIMENS REVEALED THE PRESENCE OF CANDIDA. THE CUSTOMER STATED THE SAME PATIENT SAMPLE WAS INOCULATED VIA ALTERNATE METHOD (RICE AGAR) AND GROWTH OF CANDIDA SPECIES, MOSTLY C. ALBICANS, WAS OBSERVED FOLLOWING INCUBATION. THE CUSTOMER STATED THAT NO (B)(6) RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER HAS NOT CLAIMED ANY INJURY, DEATH, UNNECESSARY MEDICAL PROCEDURE OR NEGATIVE IMPACT TO THE PATIENT DUE TO THE CHROMID AGAR BEHAVIOR. PATIENT ISOLATE SUBMITTAL HAS BEEN REQUESTED. AN INTERNAL BIOMÉRIEUX INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364231 CHROMID CANDIDA CHROMID CANDIDA AGAR JSI BIOMÉRIEUX SA 1003875550

    Patients

    Seq Age Sex Outcome Treatment
    1