BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHROMID MRSA SMART AGAR

    MDR report key: 4835804 · Received June 10, 2015

    Report

    Report Number
    3002769706-2015-00043
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    May 25, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JSO
    PMA / PMN Number
    K091024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE CHROMID (B)(6) SMART AGAR (REF. 413050, LOT 1003875350, EXP. 29MAY2015). THE SOURCE OF THE PATIENT ISOLATE IS A POST-OPERATIVE WOUND SWAB FOLLOWING ORTHOPEDIC SURGERY. THE ISOLATE WAS TESTED IN PARALLEL WITH TWO TYPES OF ISOLATION MEDIA (BIOMÉRIEUX (B)(4) BLOOD AGAR AND MCCONKEY AGAR) AND OBTAINED GROWTH OF COLONIES. A POSITIVE (B)(6) STATUS WAS DETERMINED BY PERFORMING ANTIBIOTIC SUSCEPTIBLY TEST (AST) ON ISOLATED COLONIES FROM THE AGAR PLATES VIA BIOMÉRIEUX OXACILLIN ETEST (B)(4). THE CUSTOMER REPEATED THE ISOLATE TESTING USING A DIFFERENT LOT OF CHROMID (B)(6) SMART AGAR (REF 413050; LOT 1003912880; EXPIRY 17JUN2015) AND OBTAINED POSITIVE RESULTS. PATIENT TREATMENT WAS DELAYED BY ONE DAY DUE TO THE DISCREPANT CHROMID (B)(6) SMART AGAR (LOT 1003875350) RESULT. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S STATE OF HEALTH. THE CUSTOMER CONFIRMED THAT THEY DO NOT PERFORM QUALITY CONTROL (QC) TESTS TO CHECK THE PERFORMANCE OF CHROMID (B)(6) SMART AGAR. AS MENTIONED IN THE CHROMID (B)(6) SMART AGAR INSTRUCTIONS FOR USE (REF. 413050), IT IS THE RESPONSIBILITY OF THE USER TO PERFORM QC. BIOMÉRIEUX INVESTIGATION: REVIEW OF COMPLAINT RECORDS INDICATES NO OTHER COMPLAINT HAS BEEN REGISTERED AGAINST THIS REFERENCE NUMBER AND LOT NUMBER. REVIEW OF THE BATCH RECORD CONFIRMED NO ABNORMALITIES WITH THIS PRODUCT (REF. 413050, LOT 1003875350, EXP. 29MAY2015). ALTHOUGH THE PRODUCT WAS ALREADY EXPIRED WHEN BIOMÉRIEUX BECAME AWARE OF THE ISSUE, RETAIN SAMPLES OF CHROMID (B)(6) SMART AGAR (REF. 413050; LOT 1003875350) WERE TESTED AT THE MANUFACTURING SITE USING THE SAME STRAINS AS USED DURING RELEASE TESTS AND THE EXPECTED RESULTS WERE OBTAINED. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. THE INVESTIGATION CONCLUDED THAT THE PERFORMANCE OF CHROMID (B)(6) SMART AGAR REF 413050; LOT 1003875350 IS WITHIN SPECIFICATION. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY AS A CONSEQUENCE OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376879 CHROMID MRSA SMART AGAR CHROMID MRSA SMART AGAR JSO BIOMERIEUX SA 1003875350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention