BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-308

    MDR report key: 16665392 · Received April 3, 2023

    Report

    Report Number
    1119779-2023-00355
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    January 15, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY. INITIAL REPORTER (B)(6). DEVICE EVALUATED BY MFR IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 06-MAR-2023. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR E. COLI MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-308 (449282) BATCH NUMBER: 2256570. THE CUSTOMER PROVIDED ISOLATE RETURNS, LAB REPORTS AND BINARY FILES BUT DID NOT PROVIDE PANEL RETURNS FOR THE INVESTIGATION. AS PART OF THE INVESTIGATION, THE SEVEN (7) CUSTOMER RETURNED E. COLI STRAINS FOR (B)(4)WERE RECEIVED AT BD SPARKS FOR TESTING BY THE ID/AST QUALITY GROUP. THE STRAINS WERE SUBCULTURED ON TO TRYPTICASE SOY AGAR PLUS 5% SHEEP¿S BLOOD PLATES (BD MATERIAL#: 221261) AND MACCONKEY II AGAR PLATES (BD MATERIAL#: 221270) IN PREPARATION FOR PHOENIX TESTING. ALL STRAINS WERE RUN ON RETENTION SAMPLES OF NMIC/ID-308 PHOENIX PANELS MATERIAL#: 449282, BATCH#: 2256570 ON A PHOENIX M50 INSTRUMENT. TWO (2) PANELS WERE PERFORMED FOR EACH STRAIN. FOR A TOTAL OF FOURTEEN (14) PANELS TESTED. DURING THE INVESTIGATION, CUSTOMER E. COLI ISOLATE #2 MIS IDENTIFIED AS CITROBACTER FREUNDII ON THE MACCONKEY II AGAR PLATES. IDENTIFICATION CONFIRMATION FOR STRAIN #2 WAS PERFORMED ON BRUKER MALDI-TOF. STRAIN #2 WAS IDENTIFIED AS E. COLI VIA THE BRUKER MALDI-TOF. ALL OTHER CUSTOMER PROVIDED STRAINS IDENTIFIED CORRECTLY AS E. COLI ON TRYPTICASE SOY AGAR PLUS 5% SHEEP¿S BLOOD PLATES AND MACCONKEY II AGAR PLATES. ADDITIONAL REPLICATES OF CUSTOMER ISOLATE #2 WERE SUBCULTURED ON TO TRYPTICASE SOY AGAR PLUS 5% SHEEP¿S BLOOD PLATES AND MACCONKEY II AGAR PLATES. THE STRAINS WERE RUN ON RETENTION SAMPLES OF NMIC/ID-308 PHOENIX PANELS BATCH#: 2256570 ON A PHOENIX M50 INSTRUMENT. FOR A TOTAL OF EIGHT (8) ADDITIONAL PANELS TESTED. DURING THE INVESTIGATION, CUSTOMER ISOLATE #2 MIS IDENTIFIED AS CITROBACTER FREUNDII ON THE MACCONKEY II AGAR PLATES ON THREE OUT OF THE FOUR REPLICATES. IDENTIFICATION CONFIRMATION FOR ALL REPLICATES OF STRAIN #2 WAS PERFORMED ON BRUKER MALDI-TOF. STRAIN #2 WAS IDENTIFIED AS E. COLI VIA THE BRUKER MALDI-TOF. BASED ON THE INVESTIGATION PERFORMED, THIS COMPLAINT IS CONFIRMED FOR E. COLI MIS ID. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED THREE ADDITIONAL COMPLAINTS ON COMPLAINT BATCH: 2256570, NONE OF WHICH HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    THIS REPORT IS FOR PATIENT 4 OF 33. IT WAS REPORTED, THAT WHILE USING THE PANEL PHOENIX NMIC/ID-308 ,THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THERE HAS BEEN 33 PATIENTS THIS ISSUE HAS AFFECTED. M50 WOULD ID AS ENT. CLOACAE EVEN IF IT IS INDOLE POS. IT WOULD ALSO SOMETIMES ID AS PROT, MIRABILLS OR CTIROBACTER. CUSTOMER HAS BEEN USING API 20 TO RETEST WHENEVER THEY SUSPECT A MIS-IDENTIFICATION. CUSTOMER STATES, E. COLI HAS BEEN MISIDENTIFIED AS E. CLOACAE. NO ID, AND CITROBACTER SP. FOR THE LAST 2 WEEKS.

    Description of Event or Problem · 0

    THIS REPORT IS FOR PATIENT 4 OF 33. IT WAS REPORTED THAT WHILE USING THE PANEL PHOENIX NMIC/ID-308 THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THERE HAS BEEN 33 PATIENTS THIS ISSUE HAS AFFECTED. M50 WOULD ID AS ENT. CLOACAE EVEN IF IT IS INDOLE POS. IT WOULD ALSO SOMETIMES ID AS PROT. MIRABILIS OR CITROBACTER. CUSTOMER HAS BEEN USING API 20 TO RETEST WHENEVER THEY SUSPECT A MIS-IDENTIFICATION. CUSTOMER STATES E. COLI HAS BEEN MISIDENTIFIED AS E. CLOACAE, NO ID, AND CITROBACTER SP. FOR THE LAST 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117059 PANEL PHOENIX NMIC/ID-308 SEE H.10 LON BECTON, DICKINSON & CO. (SPARKS) 2256570

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown