BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID® CPS ELITE AGAR

    MDR report key: 9788852 · Received March 4, 2020

    Report

    Report Number
    9615755-2020-00004
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Report Date
    April 7, 2020
    Manufacturer
    BIOMERIEUX S.A.
    Product Code
    JXA
    UDI-DI
    03573026443900
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SEE SECTION H11.ON 07-APR -2020 IT WAS REALIZED THAT SECTION G4 DATE RECEIVED BY MFG OF REPORT 9615755-2020-00003-01 WAS INCORRECTLY MARKED AS 03-MAR-2020. THE CORRECTED DATE FOR SECTION G4 IS 04-MAR-2020.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM FRANCE NOTIFIED BIOMÉRIEUX OF A CONTAMINATION AFTER USE IN ASSOCIATION WITH THE CHROMID® CPS ELITE AGAR (REF. 416172, LOT 1007747790) WHEN TESTING TWO SEPARATE PATIENT URINE SAMPLES. THE CUSTOMER OBSERVED CONTAMINATION ON THIRTY (30) PLATES FROM FOUR (4) BOXES OF LOT 1007747790. THE CUSTOMER NOTED TWO CONTAMINATED PLATES HAD ALREADY BEEN USED TO TEST TWO (2) SEPARATE PATIENT URINE SAMPLES. THE CONTAMINATION WAS OBSERVED AFTER INCUBATION. IN RESPONSE TO THE CUSTOMER COMPLAINT BIOMÉRIEUX COMPLETED AN INTERNAL INVESTIGATION THAT INCLUDED A REVIEW OF PRODUCTION RECORDS, REVIEW COMPLAINTS, AND TESTING OF PRODUCT RETAINS FOR LOT 1007747790. REVIEW OF PRODUCTION RECORDS SHOWED LOT 1007747790 OBTAINED PASSING QUALITY CONTROL TEST RESULTS, INCLUDING PASSING RESULTS FOR MICROBIOLOGICAL PERFORMANCE AND MICROBIOLOGICAL STATE PRIOR TO BATCH RELEASE. A REVIEW OF COMPLAINT DATA FOR LOT 1007747790 DID NOT IDENTIFY ANY TRENDS. FOUR (4) RETAINED CELLOPHANE PACKETS EACH WITH TEN (10) PLATES FROM DIFFERENT MANUFACTURING TIMES WERE INCUBATED 33-37 º C AND EXAMINED FOR CONTAMINATION EVERY TWENTY FOUR (24) HOURS. NO CONTAMINATION WAS OBSERVED ACROSS ALL PLATES. THE CONTAMINATION OBSERVED BY THE CUSTOMER WAS NOT REPRODUCED; HOWEVER, THE PLATES ARE NOT STERILIZED IN THE FINAL MANUFACTURING CONTAINER, THEREFORE CONTAMINATION CANNOT BE RULED OUT AS A POTENTIAL ROOT CAUSE. CHROMID® CPS ELITE AGAR LOT 1007747790 MET ALL QC RELEASE CRITERIA AND THERE IS NO EVIDENCE THAT SUGGESTS LOT 1007747790 IS NOT PERFORMING AS INTENDED.SEE SECTION H10.

    Additional Manufacturer Narrative · 0

    SEE SECTION H11.REPORT 9615755-2020-00004-02 MENTIONS AN INCORRECT REPORT NUMBER. THE PREVIOUS CORRECTION NOTE WAS: "ON (B)(6) 2020 IT WAS REALIZED THAT SECTION G4 DATE RECEIVED BY MFG OF REPORT 9615755-2020-00003-01 WAS INCORRECTLY MARKED AS (B)(6) 2020. THE CORRECTED DATE FOR SECTION G4 IS (B)(6) 2020." IT SHOULD HAVE SAID "ON 07-APR -2020 IT WAS REALIZED THAT SECTION G4 DATE RECEIVED BY MFG OF REPORT 9615755-2020-00004-01 WAS INCORRECTLY MARKED AS 03-MAR-2020. THE CORRECTED DATE FOR SECTION G4 IS 04-MAR-2020.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A CONTAMINATION AFTER USE IN ASSOCIATION WITH THE CHROMID® CPS ELITE AGAR (REF. 416172, LOT 1007747790) WHEN TESTING TWO SEPARATE PATIENT URINE SAMPLES. THE CUSTOMER OBSERVED CONTAMINATION ON THIRTY (30) PLATES FROM FOUR (4) BOXES OF LOT 1007747790. THE CUSTOMER NOTED TWO CONTAMINATED PLATES HAD ALREADY BEEN USED TO TEST TWO (2) SEPARATE PATIENT URINE SAMPLES. THE CONTAMINATION WAS OBSERVED AFTER INCUBATION. THE CONTAMINANT ON BOTH PLATES WAS A LARGE CREAM-COLORED MUCOUS COLONY; BRUCKER MALDI-TOF IDENTIFIED THE CONTAMINANT AS PSEUDOMONAS. THE CUSTOMER CONFIRMED BOTH CONTAMINATED PATIENT SAMPLE PLATES WERE DISCARDED AND THE RESULTS WERE NOT REPORTED TO THE TREATING PHYSICIAN. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250378 CHROMID® CPS ELITE AGAR CHROMID® CPS ELITE AGAR JXA BIOMERIEUX S.A. 1007747790 03573026443900

    Patients

    Seq Age Sex Outcome Treatment
    1