BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID® STRB AGAR

    MDR report key: 7309693 · Received March 2, 2018

    Report

    Report Number
    3002769706-2018-00025
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Report Date
    June 4, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PQZ
    PMA / PMN Number
    K163042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN HONG KONG NOTIFIED BIOMÉRIEUX OF MEDIA SHRINKAGE THAT LEAD TO A DELAYED RESULT GREATER THAN 24 HOURS WITH CHROMID® STRB AGAR (REFERENCE 43461). SHRINKAGE OF COLONIES WAS OBSERVED ON THE IMPACTED PLATES AFTER INCUBATION. THE DELAY WAS OVER 24 HOURS DUE TO REPEAT TESTING. AN INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED THAT THE AGAR WAS FOUND TO BE DRIED UP ON STORAGE INSIDE THE SEALED PLASTIC BAG AND IN THREE UNOPENED BOXES. THE CUSTOMER ALSO REPORTED THAT THE THICKNESS OF THE AGAR WAS TOO THIN TO BE USED. THE MANUFACTURING TIMES OF THE IMPACTED PLATES ARE THE FOLLOWING 16:53, 16:54, 16:55, 16:56. THE CUSTOMER PROVIDED PHOTOS OF THE PLATES. IT WAS NOT POSSIBLE TO TEST THE RETAINED SAMPLE PLATES FOR THE IMPACTED LOT NUMBER AS THE LOT HAD ALREADY EXPIRED AT THE TIME OF THE INVESTIGATION. A REVIEW OF QUALITY RECORDS FOR THE IMPACTED LOT NUMBER 1006032880 INDICATED THE QUALITY CONTROL OF THE WEIGHT AND THE QUALITY CONTROL OF THE APPEARANCE OF THE PRODUCT CONFORMED WITH SPECIFICATIONS FOR THE WHOLE DURATION OF THE MANUFACTURING PROCESS. MICROBIOLOGICAL ACTIVITY QUALITY CONTROLS CONFORMED WITH SPECIFICATIONS IN TERMS OF FERTILITY AND SELECTIVITY. THE PH OF THE LOT NUMBER CONFORMED WITH SPECIFICATIONS. THE QUALITY CONTROL OF THE LOT CONFORMED WITH SPECIFICATIONS. NONCONFORMITIES AND DEVIATIONS WERE NOT RECORDED ON THIS LOT NUMBER. NONCONFORMITIES RELATED TO THE TIME OUT OF RANGE (TIME OUTSIDE THE OPTIMUM TEMPERATURE RANGE DURING THE SHIPMENT OF THE PRODUCT) FROM THE INTERNATIONAL DISTRIBUTION CENTRE TO THE SUBSIDIARY, WERE NOT REGISTERED FOR LOT NUMBER 1006032880, REFERENCE 43461. IN CONCLUSION, THE REVIEW OF THE LOT NUMBER FILE DID NOT INDICATE ANY CONNECTION WITH THE ISSUE OBSERVED BY THE CUSTOMER. IN ADDITION, NO OTHER COMPLAINTS WERE REGISTERED FOR SHRINKAGE OF THE MEDIA AND NON CONFORMITIES RELATED TO TIME OUT OF RANGE DURING THE SHIPMENT WERE ALSO NOT REGISTERED. THE HYPOTHESIS TO EXPLAIN THE DEHYDRATION (SHRINKAGE) OF THE PLATES COULD BE DUE TO THE STORAGE CONDITIONS OF THE PRODUCT. THE EVENT APPEARS TO BE AN ISOLATED ISSUE. OF NOTE, THE PACKAGE INSERT STATES "READING AND INTERPRETATION · AFTER INCUBATION, OBSERVE THE BACTERIAL GROWTH AND THE APPEARANCE OF THE COLONIES: TYPICAL STREPTOCOCCUS AGALACTIAE COLONIES ARE PALE PINK TO RED, ROUND AND PEARLY. THEY MUST BE CONFIRMED USING A BIOCHEMICAL OR IMMUNOLOGICAL TEST, FOR EXAMPLE, THE SLIDEX® STREPTO B REAGENT. "

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF MEDIA SHRINKAGE THAT LEAD TO A DELAYED RESULT GREATER THAN 24 HOURS WITH CHROMID® STRB AGAR (REFERENCE 43461). THE CUSTOMER REPORTED THAT THE MEDIA SHRINKAGE WAS OBSERVED ON SOME PLATES AFTER INCUBATION. HOWEVER, THIS ISSUE HAS CAUSED DELAYED RESULTS GREATER THAN 24 HOURS DUE TO REPEAT TESTING. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152579 CHROMID® STRB AGAR CHROMID® STRB AGAR PQZ BIOMERIEUX SA 1006032880

    Patients

    Seq Age Sex Outcome Treatment
    1