BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX CHECK-POINTS CPO IVD

    MDR report key: 16429471 · Received February 23, 2023

    Report

    Report Number
    1119779-2023-00171
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 19, 2023
    Report Date
    March 24, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    POC
    PMA / PMN Number
    K190613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED; B.5. EVENT DESCRIPTION UPDATED TO INCLUDE THE CORRECT BRAND NAME. KIT BD MAX CHECK-POINTS CPO IVD. D.1. MEDICAL DEVICE BRAND NAME: KIT BD MAX CHECK-POINTS CPO IVD. D.4. MEDICAL DEVICE CATALOG #: 278102. D.4. MEDICAL DEVICE LOT # : 2017254. D.4. MEDICAL DEVICE EXPIRATION DATE: 10/07/2022. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00171 WAS SENT IN ERROR. THE PRODUCT INVOLVED IS NOT SOLD WITHIN THE US AND BD DOES NOT SELL A SIMILAR PRODUCT WITHIN THE US AND/OR IT IS NOT A REGISTERED MEDICAL DEVICE IN THE US. THIS COMPLAINT IS NOT MDR REPORTABLE.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, ANTIMICROBIAL RESISTANCE MARKER, DIRECT SPECIMEN. 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 · 0

    IT WAS REPORTED THAT USING KIT BD MAX CHECK-POINTS CPO IVD FALSE NEGATIVES HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX CT0488 A5, RUN 2922 - NDM AND VIM POSITIVE. NGS STRAINS CULTURED POSITIVE: KPC, OXA-48, NDM, VIM. FALSE NEGATIVE: KPC AND OXA-48. MAX CT0488 B2, RUN 2933 - ALL NEGATIVE. NGS STRAINS CULTURED POSITIVE: VIM AND OXA-48. FALSE NEGATIVE: VIM AND OXA-48.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT KIT BD MAX CPO FALSE NEGATIVES HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX CT0488 A5, RUN 2922 - NDM AND VIM POSITIVE. NGS STRAINS CULTURED POSITIVE: KPC, OXA-48, NDM, VIM. FALSE NEGATIVE: KPC AND OXA-48. MAX CT0488 B2, RUN 2933 - ALL NEGATIVE. NGS STRAINS CULTURED POSITIVE: VIM AND OXA-48. FALSE NEGATIVE: VIM AND OXA-48.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678378 KIT BD MAX CHECK-POINTS CPO IVD SEE H.10 POC BECTON, DICKINSON & CO. (SPARKS) 2017254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown