BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 17099672 · Received June 9, 2023

    Report

    Report Number
    1119779-2023-00634
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 13, 2023
    Report Date
    August 22, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486076
    PMA / PMN Number
    K040106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: 2023-06-22. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR UNUSUAL DAPTOMYCIN (DAP) RESULTS, AND HIGH LEVELS OF GENTAMICIN (GMS) AND STREPTOMYCIN (STS) RESISTANCE WITH ENTEROCOCCUS FAECALIS WHEN USING PHOENIX PANEL PMIC/ID-107 (448607) BATCH NUMBER 1022644. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT DID PROVIDE PHOENIX GENERATED LAB REPORTS AND E. FAECALIS ISOLATE RETURNS FOR THE INVESTIGATION. REVIEW OF THE CUSTOMER PROVIDED PHOENIX LAB REPORTS INDICATES THAT THE PANEL BATCH # PRINTED ON THE LAB REPORTS WAS #1022644 HOWEVER, BATCH #1022644 IS NOT ASSOCIATED WITH PHOENIX PANEL PMIC/ID-107 (448607). FURTHER INVESTIGATION OF THE PANEL SEQUENCE NUMBERS ON THE LAB REPORTS VERIFIED THAT THE ASSOCIATED SEQUENCE NUMBERS CORRELATE TO PANEL BATCH #2264434. NOTE CUSTOMER ISOLATE ACCESSION #(B)(6) WAS A MIXED CULTURE AND NOT USED FOR TESTING. TO INVESTIGATE, RETENTION PANELS FROM PANEL BATCH 2264434 WERE TESTED USING SIX (6) OF THE CUSTOMERS RETURNED E. FAECALIS ISOLATES ON A PHOENIX M50 INSTRUMENT AND EVALUATED FOR DAP, GMS AND STS MIC RESULTS. IN ADDITION, DISC DIFFUSION WAS PERFORMED FOR IPM AND STS. NOTE: CLSI DOES NOT PROVIDE DISC ZONE SIZE INTERPRETATIONS FOR DAP AND E. FAECALIS. SEE TABLE 1 (ATTACHED) FOR COMPREHENSIVE SUMMARY OF PHOENIX AND DISC INTERP RESULTS. NOTE BD DOES NOT CONFIRM ON AN INTERMEDIATE (I) RESULT AS IT IS ONE DILUTION OFF FROM S OR R. BASED ON THE INVESTIGATION PERFORMED, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT ON THE COMPLAINT BATCH, NOT RELATED TO THIS DEFECT (FALSE RESISTANCE) AND NOT CONFIRMED. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT (FALSE RESISTANCE) ACROSS THIS PANEL SKU (#448607).

    Additional Manufacturer Narrative · 0

    LOT 1022644 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #448607. D.3 COMMON DEVICE NAME: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY. D4. MEDICAL DEVICE LOT #: 1022644 D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN H.3. 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 5 OUT OF 7. IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-107 THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 7 EXAMPLES PROVIDED. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO. DID A SERIOUS INJURY OCCUR? NO. DID ERRONEOUS RESULTS OCCUR? YES. CUSTOMER PROBLEM: ENTEROCOCCUS FAECALIS UNUSUAL RESULTS_ DAPTOMYCIN>4 NO INTERPRETATION, HIGH LEVEL GENTAMICIN RESISTANCE, HIGH LEVEL STREPTOMYCIN RESISTANCE WITH USE OF PMIC/ID 107 PANEL LOT 1022644. CUSTOMER REPORTING MIC DISCREPANCIES WITH STREPTOMYCIN, GENTAMICIN, AND DAPTOMYCIN WITH 7 PATIENTS.

    Description of Event or Problem · 0

    REPORT 5 OUT OF 7. IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-107 THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): 7 EXAMPLES PROVIDED HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO DID A SERIOUS INJURY OCCUR? NO DID ERRONEOUS RESULTS OCCUR? YES CUSTOMER PROBLEM: ENTEROCOCCUS FAECALIS UNUSUAL RESULTS DAPTOMYCIN>4 NO INTERPRETATION, HIGH LEVEL GENTAMICIN RESISTANCE, HIGH LEVEL STREPTOMYCIN RESISTANCE WITH USE OF PMIC/ID 107 PANEL LOT 1022644. CUSTOMER REPORTING MIC DISCREPANCIES WITH STREPTOMYCIN, GENTAMICIN, AND DAPTOMYCIN WITH 7 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188494 BD PHOENIX¿ PMIC/ID-107 NA LON BECTON, DICKINSON & CO. (SPARKS) 448607 UNKNOWN 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown