BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID® STREPTO B AGAR

    MDR report key: 7611466 · Received June 18, 2018

    Report

    Report Number
    3002769706-2018-00079
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Report Date
    September 27, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PQZ
    PMA / PMN Number
    K163042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: A DISCREPANCY OR ANOMALY WAS NOT OBSERVED DURING A REVIEW OF THE DEVICE HISTORY RECORDS. THE PRODUCT WAS CONFIRMED TO BE WITHIN MANUFACTURING SPECIFICATIONS. A REVIEW OF THE COMPLAINT HISTORY INDICATED THERE WERE NO OTHER COMPLAINTS SIMILAR IN NATURE TO THE ONE REPORTED BY THE CUSTOMER. AS THE LOT HAD ALREADY EXPIRED WHEN THE INVESTIGATION STARTED, IT WAS NOT POSSIBLE TO INVESTIGATE THE ISSUE ANY FURTHER. AS THE ISSUE IS ISOLATED, NEITHER CORRECTIVE NOR PREVENTIVE ACTIONS WILL BE IMPLEMENTED. COMPLAINTS WILL CONTINUE TO BE MONITORED ON THIS REFERENCE.

    Description of Event or Problem · 1

    A CUSTOMER IN UKRAINE CONTACTED BIOMÉRIEUX TO REPORT SHRINKAGE OF THE AGAR FOLLOWING INCUBATION IN ASSOCIATION WITH THE CHROMID® STREPTO B KIT. THE CUSTOMER INDICATED A DELAY IN REPORTING OF >24 HOURS DUE TO THE NEED FOR RETEST OF THE SPECIMEN. THE DURATION OF INCUBATION AND THE TYPE OF INCUBATION WERE NOT PROVIDED BY THE CUSTOMER. IT IS ALSO NOTED THE AGAR LOT IN USE WAS WITHIN ONE DAY OF EXPIRATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN TO BIOMÉRIEUX THAT THE DELAY IN REPORTING LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453879 CHROMID® STREPTO B AGAR CHROMID® STREPTO B AGAR PQZ BIOMERIEUX SA 1006257280

    Patients

    Seq Age Sex Outcome Treatment
    1