BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC ID 208

    MDR report key: 11374909 · Received February 24, 2021

    Report

    Report Number
    1119779-2021-00383
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THIS COMPLAINT IS DUE TO FALSE SUSCEPTIBILITY OF MEROPENEM WHEN USING PHOENIX PANEL NMIC/ID-208 (448739) BATCH 0231102. NO INFORMATION ON ISOLATES, LAB REPORTS, PRODUCT RETURNS OR ISOLATES WERE PROVIDED FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF THREE (3) RETENTION PANELS FROM THE COMPLAINT BATCH WERE TESTED USING VARIOUS IN HOUSE ISOLATES AND TESTED USING A PHOENIX 100 INSTRUMENT. ONE (1) PANEL WAS TESTED WITH AN IN HOUSE ISOLATE OF KLEBSIELLA PNEUMONIAE 18015, ONE (1) PANEL WAS TESTED WITH AN IN HOUSE ISOLATE OF ENTER. ASBURIAE 18097 AND ONE (1) PANEL WAS TESTED WITH AN IN HOUSE ISOLATE OF ENTER. CLOACAE 21818. AT THE END OF THE RUN, ALL THREE (3) PANELS YIELDED MICS >4 FOR RESISTANT RESULTS FOR MEROPENEM. 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 (1) ADDITIONAL COMPLAINT FOR THIS BATCH, BUT NOT RELATED TO THIS DEFECT. COMPLAINT TRENDING WAS PERFORMED AND A TREND WAS IDENTIFIED FOR THIS DEFECT (LOW MIC RESULTS) IN APRIL 2020. BASED ON THE SEVERITY AND RATE OF THE DEFECT, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS NOT INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC ID 208 NO MIC RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CARBANP AND MCIM TEST WERE USED TO CONFIRM THE RESULTS. THE CUSTOMER STATED ERRONEOUS RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THIS PRODUCT IS NOT SOLD IN THE US. IT MAY BE SIMILAR TO OTHER PRODUCT CURRENTLY REGISTERED FOR SALE IN THE US. INVESTIGATION IS ON GOING TO DETERMINE WHICH PRODUCT IS MOST SIMILAR. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC ID 208 NO MIC RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CARBANP AND MCIM TEST WERE USED TO CONFIRM THE RESULTS. THE CUSTOMER STATED ERRONEOUS RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267268 PANEL PHOENIX NMIC ID 208 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1