BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-308

    MDR report key: 16625212 · Received March 27, 2023

    Report

    Report Number
    1119779-2023-00330
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    February 27, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    UNK
    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

    AS A RESULT OF A PRODUCT NUMBER CHANGE, THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B.5. UPDATED WITH CORRECT MEDICAL DEVICE BRAND NAME: PANEL PHOENIX NMIC/ID-308. D4. MEDICAL DEVICE CATALOG #: 449282. D4. MEDICAL DEVICE EXPIRATION DATE: 30-09-2023. D.4. UDI #: (B)(4). D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 03-MAR-2023. H4. DEVICE MANUFACTURE DATE: 13-09-2022. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR PROTEUS MIRABILIS 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 ONE (1) CUSTOMER RETURNED STRAIN WAS RECEIVED AT BD SPARKS FOR TESTING BY THE ID/AST QUALITY GROUP. THE STRAIN WAS 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. THE STRAIN WAS RUN ON RETENTION SAMPLES OF NMIC/ID-308 PHOENIX PANELS MATERIAL #449282 BATCH #2256570 ON A PHOENIX M50 INSTRUMENT. DURING THE INVESTIGATION, ALL REPLICATES IDENTIFIED CORRECTLY AS P. MIRABILIS. IDENTIFICATION CONFIRMATION FOR ALL REPLICATES WAS PERFORMED ON BRUKER MALDI-TOF. THE STRAIN WAS IDENTIFIED AS P. MIRABILIS VIA THE BRUKER MALDI-TOF. BASED ON THE INVESTIGATION PERFORMED, THIS COMPLAINT IS NOT CONFIRMED FOR P. MIRABILIS 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. THE TRENDING FOR P. MIRABILIS WAS REVIEWED AND DOES NOT SHOW AN INCREASE OF MIS IDS OVER THE PAST YEAR. ALTHOUGH WE DIDN'T SEE THE ISSUE WITH THE CUSTOMER RETURNED ISOLATE, BD IS STILL ASSESSING THE FEASIBILITY OF POSSIBLE IMPROVEMENTS FOR OTHER COMMON GRAM-NEGATIVE ORGANISMS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY. 256570 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE:UNKNOWN INITIAL REPORTER E-MAIL: (B)(6). 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

    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: PLEASE PROVIDE AS MUCH INFORMATION AS CAN BE PROVIDED, THE FOLLOWING LOT NUMBERS, SEQUENCE NO, CATALOGUE NO., AND STORAGE CONDITIONS IS VERY IMPORTANT. PANEL: 2256570. WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. CUSTOMER INDICATES THAT A PANEL CAME OFF THE M50 THAT WAS SUPPOSED TO BE A PROTEUS MIRABILIS THAT CAME OFF AS AN E.COLI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX PANEL NMIC-306 THAT THERE WAS MISIDENTIFICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLEASE PROVIDE AS MUCH INFORMATION AS CAN BE PROVIDED, THE FOLLOWING LOT NUMBERS, SEQUENCE NO, CATALOGUE NO., AND STORAGE CONDITIONS IS VERY IMPORTANT PANEL: 2256570 WAS THIS ISSUE INVOLVING PATIENT OR NONPATIENT SAMPLES? PATIENT. CUSTOMER INDICATES THAT A PANEL CAME OFF THE M50 THAT WAS SUPPOSED TO BE A PROTEUS MIRABILIS THAT CAME OFF AS AN E.COLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420538 PANEL PHOENIX NMIC/ID-308 SEE H.10 LON BECTON, DICKINSON & CO. (SPARKS) 2256570

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown