BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX NID

    MDR report key: 11579784 · Received March 27, 2021

    Report

    Report Number
    1119779-2021-00572
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    February 21, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904480074
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-22. INVESTIGATION SUMMARY: THIS COMPLAINT IS ONLY APPLICABLE TO US PANEL FORMATS ONLY. THIS COMPLAINT IS DUE TO MIS-IDENTIFICATIONS FOR ENTEROBACTER CLOACAE AS CITROBACTER AS WELL AS FOR SALMONELLA AS ESCHERICHIA COLI USING PHOENIX PANEL NID (448007) FOR THE FOLLOWING BATCHES: 0071509, 0308945 & 0338282. NO LAB RESULT REPORTS WERE PROVIDED, HOWEVER THE CUSTOMER RETURNED BOTH ISOLATES AND ONE (1) PANEL FROM BATCH 0338282. TO INVESTIGATE THE MIS-IDENTIFICATIONS OF ENTEROBACTER CLOACAE AS CITROBACTER, A PHOENIX M50 INSTRUMENT WAS USED TO TEST A TOTAL OF ELEVEN (11) PANELS, USING THE CUSTOMER'S RETURNED ISOLATE OF ENTEROBACTER CLOACAE. TWO (2) RETENTION PANELS FROM BATCH 0071509 AND TWO (2) PANELS FROM BATCH 0308945 WERE TESTED AND YIELDED THE CORRECT IDENTIFICATION OF ENTEROBACTER CLOACAE. SIX (6) RETENTION PANELS FROM BATCH 0338282 WERE TESTED. AT THE END OF THE RUN, FIVE (5) PANELS YIELDED THE CORRECT IDENTIFICATION OF ENTEROBACTER CLOACAE AND ONE (1) YIELDED AN IDENTIFICATION OF CITROBACTER BRAAKII. ONE (1) CONTROL PANEL FROM A DIFFERENT BATCH WAS TESTED AND YIELDED THE CORRECT IDENTIFICATION OF ENTEROBACTER CLOACAE. TO INVESTIGATE THE MIS-IDENTIFICATION OF SALMONELLA AS ESCHERICHIA COLI, A PHOENIX M50 INSTRUMENT WAS USED TO TEST TOTAL OF SIX (6) PANELS, USING THE CUSTOMER'S RETURNED ISOLATE OF SALMONELLA. TWO (2) RETENTION PANELS FROM BATCH 0071509, TWO (2) RETENTION PANELS FROM BATCH 0308945, ONE (1) RETENTION PANEL FROM BATCH 0338282 AND ONE (1) CUSTOMER'S RETURNED PANEL FROM BATCH 0338282 WERE TESTED. AT THE END OF THE RUN, ALL SIX (6) PANELS YIELDED AN IDENTIFICATION OF ESCHERICHIA COLI. THIS COMPLAINT IS CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED ONE (1) ADDITIONAL COMPLAINT ON THE COMPLAINT BATCH 0071509, AND NO ADDITIONAL COMPLAINTS FOR THE OTHER BATCHES 0308945 AND 0338282. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ NID A MIS-ID WAS OBSERVED BY THE LABORATORY PERSONNEL. A REFERENCE LAB WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS MIS-IDENTIFICATIONS ON MULTIPLE ISOLATES OF SALMONELLA AS E.COLI AND ENTEROBACTER CLOACAE AS CITROBACTER. MULTIPLE TIMES CUSTOMER HAS HAD MULTIPLE INSTANCES OF SALMONELLA ID ON BRUKER MALDI, PROTOCOL FOR ID IS TO HAVE ANOTHER METHOD PERFORMED FOR THIS ORGANISM. THEY WOULD USUALLY USE RAPIDONE HOWEVER THEY HAVE BEEN OUT SO THEY UTILIZED NID ON M50 AND GET E.COLI. THEY END UP SENDING THE ISOLATE FOR CONFIRMATION AND GOT CONFIRMATION OF SALMONELLA. ISOLATE IDENTIFIED AS ENTEROBACTER CLOACAE ON BRUKER MALDI BUT WITH LOW CONFIDENCE SO SET ON M50 AND GOT CITROBACTER WITH 90% CONFIDENCE. SINCE IDENTIFICATION DID NOT MATCH, THEY HAVE SENT ISOLATE TO REFERENCE LAB TO CONFIRM. PENDING RESULTS REQUESTED LAB REPORTS AND ISOLATE AVAILABILITY ALONG WITH LOT NUMBERS INVOLVED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0071509. MEDICAL DEVICE EXPIRATION DATE: 2021-03-31. DEVICE MANUFACTURE DATE: 2020-03-11. MEDICAL DEVICE LOT #: 0308945. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. DEVICE MANUFACTURE DATE: 2020-11-03. MEDICAL DEVICE LOT #: 0338282. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2020-12-03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ NID A MIS-ID WAS OBSERVED BY THE LABORATORY PERSONNEL. A REFERENCE LAB WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS MIS-IDENTIFICATIONS ON MULTIPLE ISOLATES OF SALMONELLA AS E.COLI AND ENTEROBACTER CLOACAE AS CITROBACTER. MULTIPLE TIMES CUSTOMER HAS HAD MULTIPLE INSTANCES OF SALMONELLA ID ON BRUKER MALDI, PROTOCOL FOR ID IS TO HAVE ANOTHER METHOD PERFORMED FOR THIS ORGANISM. THEY WOULD USUALLY USE RAPIDONE HOWEVER THEY HAVE BEEN OUT SO THEY UTILIZED NID ON M50 AND GET E.COLI. THEY END UP SENDING THE ISOLATE FOR CONFIRMATION AND GOT CONFIRMATION OF SALMONELLA. ISOLATE IDENTIFIED AS ENTEROBACTER CLOACAE ON BRUKER MALDI BUT WITH LOW CONFIDENCE SO SET ON M50 AND GOT CITROBACTER WITH 90% CONFIDENCE. SINCE IDENTIFICATION DID NOT MATCH, THEY HAVE SENT ISOLATE TO REFERENCE LAB TO CONFIRM. PENDING RESULTS. REQUESTED LAB REPORTS AND ISOLATE AVAILABILITY ALONG WITH LOT NUMBERS INVOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477353 BD PHOENIX NID GRAM NEGATIVE IDENTIFICATION PANEL LON BECTON, DICKINSON & CO. (SPARKS) 448007 SEE H.10. 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1