BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NID

    MDR report key: 17213839 · Received June 27, 2023

    Report

    Report Number
    1119779-2023-00722
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 6, 2023
    Report Date
    October 13, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LQM
    UDI-DI
    30382904480074
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN CORRECTED AS A RESULT OF A MATERIAL NUMBER CHANGE. B.5. DESCRIBE EVENT OR PROBLEM: UPDATED BASED ON MATERIAL NUMBER CHANGE. D1: MEDICAL DEVICE BRAND NAME: BD PHOENIX¿ NID. D2A: COMMON DEVICE NAME: GRAM NEGATIVE IDENTIFICATION PANEL. D4. MEDICAL DEVICE CATALOG #: 448007. D4. MEDICAL DEVICE LOT#: 2263221. D4. MEDICAL DEVICE TYPE: LQM. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE EXPIRATION DATE: 10-31-2023. F.10. IMDRF ANNEX F GRID CODE: UP: UPDATED TO F26. G.5. PMA / 510(K)#: EXEMPT. H4. DEVICE MANUFACTURE DATE: 10-09-2022. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS CITROBACTER KOSERI AND PROTEUS MIRABILIS AS PROVIDENCIA RETTGERI WHEN USING PHOENIX PANEL NID (448007) BATCH NUMBER 2263221. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS, BINARY FILES AND ISOLATE RETURNS FOR THE INVESTIGATION. THE LAB REPORTS SHOW PATIENT SAMPLES MISIDENTIFIED AS C. KOSERI AND P. RETTGERI. TO INVESTIGATE, TWO RETENTION PANELS FROM COMPLAINT BATCH 2263221 WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI 3-8128869 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. NEXT, TWO RETENTION PANELS FROM COMPLAINT BATCH 2263221 WAS TESTED USING QC ISOLATE P. MIRABILIS A29906 ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR IDENTIFICATION RESULTS. ALL FOUR PANELS RETURNED THE EXPECTED IDENTIFICATION RESULTS; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 1 OF 3. IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ NID, E. COLI WAS MISIDENTIFIED AS CITROBACTER SPP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECEIVED EMAIL FROM CX, NID RESULTS INCONGRUENT WITH COLONY MORPHOLOGY AND VITEK GN (INITIAL PHOENIX ID: CITROBACTER SPP, ACTUAL ID: E.COLI; INITIAL PHOENIX ID: PROVIDENCIA SPP, ACTUAL ID: PROTEUS MIRABILIS). MISIDENTIFICATION OF CLINICAL MICROBIOLOGICAL ORGANISMS DID NOT IMPACT ANY PATIENT TREATMENT."

    Description of Event or Problem · 0

    REPORT 1 OF 3 IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM, E. COLI WAS MISIDENTIFIED AS CITROBACTER SPP. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHOENIX M50 NID MISIDENTIFICATION; NID RESULTS INCONGRUENT WITH COLONY MORPHOLOGY AND VITEK GN (INITIAL PHOENIX ID: CITROBACTER SPP, ACTUAL ID: E.COLI) CORRECTED REPORT, CUSTOMER REPORTED CITROBACTER WHEN ISOLATE WAS E.COLI; NO CHANGE IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120412 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON, DICKINSON & CO. (SPARKS) 443624 2263221 30382904480074
    1578658 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON, DICKINSON & CO. (SPARKS) 443624 2263221 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown