BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    API 20 C AUX 25 STRIPS+25MEDIA

    MDR report key: 11439039 · Received March 8, 2021

    Report

    Report Number
    9615754-2021-00025
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JXB
    UDI-DI
    03573026048082
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN JAPAN REGARDING A DISCREPANT RESULT USING API® 20 C AUX 25 STRIPS+25MEDIA (REF. 20210). THE LOT NUMBER IS UNKNOWN. THE BLOOD SAMPLE WAS IDENTIFIED AS CRYPTOCOCCUS NEOFORMANS WITH API® 20 C AUX, AND CANDIDA GLABRATA WAS IDENTIFIED WHEN THE SAME SAMPLE WAS OUTSOURCED FOR MASS SPECTROMETRY. THE CORRECT SAMPLE IDENTIFICATION WAS NOT CONFIRMED VIA REFERENCE METHOD. THE CUSTOMER¿S STRAIN WAS UNAVAILABLE FOR SUBMISSION/TESTING FOR THE INVESTIGATION. THE COMPLAINT TREND ANALYSIS DID NOT SHOW ANY SIGNIFICANT INCREASE IN COMPLAINTS ON THE PRODUCT API 20 C AUX DURING THE ANALYZED PERIOD. NO SIMILAR MISIDENTIFICATION ISSUE HAS BEEN REPORTED BETWEEN CRYPTOCOCCUS NEOFORMANS AND CANDIDA GLABRATA. THE API® 20 C AUX V5.0 DATABASE ANALYSIS PERFORMED SHOWED ELEVEN (11) DIFFERENT DISCRIMINATING TESTS (2KG, XYL, GAL, INO, SOR, MDG, NAG, MAL, SAC, MLZ AND RAF) BETWEEN CRYPTOCOCCUS NEOFORMANS AND CANDIDA GLABRATA. THESE TESTS WERE EXPECTED TO BE NEGATIVE FOR CANDIDA GLABRATA AND POSITIVE FOR CRYPTOCOCCUS NEOFORMANS. AS THE STRAIN IN QUESTION WAS NOT AVAILABLE FOR TESTING AND THE IMPACTED LOT NUMBER IS UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE THE REPORTED ISSUE ANY FURTHER. THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT PERFORMANCE ISSUE. COMPLAINTS WILL CONTINUE TO BE MONITORED ON THIS REFERENCE PRODUCT.

    Description of Event or Problem · 1

    A CLIENT FROM (B)(6) NOTIFIED BIOMÉRIEUX THAT HE OBSERVED A DISCREPANT RESULT USING API® 20 C AUX 25 STRIPS+25MEDIA (REF. (B)(4). THE LOT NUMBER AT THIS STAGE OF THE COMPLAINT IS UNKNOWN. THE CLIENT TESTED A BLOOD SAMPLE FROM A PATIENT WITH API® 20 C AUX 25 STRIPS+25MEDIA AND MASS SPECTROMETRY. SUMMARY: API 20 C AUX: CRYPTOCOCCUS NEOFORMANS MASS SPECTROMETRY: CANDIDA GRABLATA THE CORRECT IDENTIFICATION IS UNKNOWN. THE PATIENT DIED BEFORE THE TEST. THE CUSTOMER STATED THAT API 20 C AUX 25 STRIPS+25MEDIA IDENTIFICATION RESULT DID NOT CAUSE PATIENT DEATH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329248 API 20 C AUX 25 STRIPS+25MEDIA API® 20 C AUX 25 STRIPS+25MEDIA JXB BIOMERIEUX, SA 20210 03573026048082

    Patients

    Seq Age Sex Outcome Treatment
    1