BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIAGNOSTIC SYSTEMS PHOENIX PANEL NMIC-306

    MDR report key: 12684842 · Received October 22, 2021

    Report

    Report Number
    1119779-2021-01700
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 27, 2021
    Report Date
    July 19, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    K132674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR FALSE RESISTANT RESULTS OF MEROPENEM WHEN USING PHOENIX PANEL NMIC-306 (449292) BATCH NUMBERS 1166021, 1159944, 1159886, AND 1075245. THE CUSTOMER RETURNED PANELS, BUT DID NOT RETURN ISOLATES OR LAB REPORTS. BATCH 1075245 WAS NOT AVAILABLE FOR TESTING. TO INVESTIGATE, FOUR RETENTION PANELS FROM EACH COMPLAINT BATCH APART FROM 1075245 DUE TO IT BEING EXPIRED AT THE TIME OF INVESTIGATION. THE PANELS WERE TESTED USING QC ISOLATES OF ESCHERICHIA COLI ((B)(6)) AND IN HOUSE ISOLATES OF KLEBSIELLA PNEUMONIAE (14780), TWO PANELS PER ISOLATE ON A PHOENIX INSTRUMENT AND EVALUATED FOR MEROPENEM (MEM) MIC RESULTS. DURING INVESTIGATION, ALL PANELS YIELDED SATISFACTORY MIC RESULTS FOR MEROPENEM (MEM). THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCHES. 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 DIAGNOSTIC SYSTEMS PHOENIX PANEL NMIC-306 FALSE RESISTANCE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REFERENCE LAB WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. ¿ THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THEIR NMIC-306 PANELS ARE CALLING RESISTANCE TO MEROPENEM, WHEN REFERENCE LAB (AGAR DILUTION) IS RESULTING SENSITIVE TO MEROPENEM."

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1166021, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2021-06-15. MEDICAL DEVICE LOT #: 1159944, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2021-06-08. MEDICAL DEVICE LOT #: 1159886, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2021-06-08. MEDICAL DEVICE LOT #: 1075245, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2021-03-16. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD DIAGNOSTIC SYSTEMS PHOENIX PANEL NMIC-306 FALSE RESISTANCE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REFERENCE LAB WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THEIR NMIC-306 PANELS ARE CALLING RESISTANCE TO MEROPENEM, WHEN REFERENCE LAB (AGAR DILUTION) IS RESULTING SENSITIVE TO MEROPENEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578454 BD DIAGNOSTIC SYSTEMS PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 1166021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown