BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18181479 · Received November 21, 2023

    Report

    Report Number
    1119779-2023-01258
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 25, 2023
    Report Date
    January 11, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492892
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL? YES. D.9. RETURNED TO MANUFACTURER ON: 04-DEC-2023. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF SERRATIA MARCESCENS AS ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213335. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS, AN ISOLATE AND PANELS FOR THE INVESTIGATION. THE LAB REPORTS SHOW AN ISOLATE IDENTIFIED AS S. MARCESCENS AND E. CLOACAE WHEN USING THE COMPLAINT BATCH. THE ISOLATE WAS VERIFIED AS S. MARCESCENS WITH BRUKER MALDI BIOTYPER. TO INVESTIGATE, THREE CUSTOMER RETURNED PANELS FROM COMPLAINT BATCH 3213335 WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS U-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, TWO RETENTION PANELS FROM COMPLAINT BATCH 3213335 WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS U-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. LAST, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE S. MARCESCENS U-1 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL SEVEN PANELS IDENTIFIED THE ISOLATE AS S. MARCESCENS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. WHILE THERE HAS BEEN AN OBSERVATION OF A PERFORMANCE FAILURE BY THE CUSTOMER, BD HAS NOT BEEN ABLE TO REPLICATE THE FAILURE THROUGH INVESTIGATIVE TESTING. AN OVERALL REVIEW OF GRAM NEGATIVE PERFORMANCE IS ON-GOING AND WILL CONTINUE TO BE INVESTIGATED. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED NINE ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213335, RELATED TO THIS DEFECT AND UNCONFIRMED. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    G.5. PMA/510(K)#: THE PANEL PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K032655, K062944, K060444, K063811, K151320, K063301, K031530, K060447, K023634, K020322, K132674, K023858, K071623, K031699, K060447, K024153, K060214, K042932 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE PANEL PHOENIX NMIC/ID-307 HAS BEEN FOUND EXPERIENCING MISIDENTIFICATION. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THEY OBTAINED AN ID OF SERRATIA MARCESCENS WHILE USING NMIC/ID AND GOT A DIFFERENT ID (ENTEROBACTER CLOACAE) ON AN NID FOR THE SAME ORGANISM. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO. DID AN INJURY OCCUR? NO. DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): MIS-ID. IF YES¿WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): NO - CUSTOMER DID NOT REPORT ID. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE PANEL PHOENIX NMIC/ID-307 HAS BEEN FOUND EXPERIENCING MISIDENTIFICATION. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THEY OBTAINED AN ID OF SERRATIA MARCESCENS WHILE USING NMIC/ID AND GOT A DIFFERENT ID (ENTEROBACTER CLOACAE) ON AN NID FOR THE SAME ORGANISM. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO. DID AN INJURY OCCUR? NO. DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): MIS-ID. IF YES¿WAS PATIENT TREATMENT CHANGED IN RESULT OF ERRONEOUS RESULTS (PROVIDE DETAILS): NO - CUSTOMER DID NOT REPORT ID. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577630 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3213335 00382904492892

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown