BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC BACTERIAL PANEL

    MDR report key: 17561328 · Received August 16, 2023

    Report

    Report Number
    3007420875-2023-00080
    Event Type
    Malfunction
    Date Received
    August 16, 2023
    Date of Event
    June 14, 2023
    Report Date
    September 11, 2023
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCI
    UDI-DI
    00382904429638
    PMA / PMN Number
    K140111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. IT WAS DETERMINED BY MANAGEMENT THAT THIS IS NOT A PRODUCT COMPLAINT, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    H.3. 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

    REPORT 1 OF 4. IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL PATIENT RESULT WAS POSITIVE FOR VIBRIO ON (B)(6) AND ON REPEAT WAS NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THAT ONE PATIENT RESULT WAS POSITIVE FOR VIBRIO ON (B)(6) AND REPEATED IN DUPLICATE ON (B)(6) AND WERE NEGATIVE. ACCESSION #(B)(6), RUN#1206/1209, POSITION A9/A3 & A4, ENTERIC LOT# 3088948, EXTENDED LOT# 2355384, INITIAL RESULT VIBRIO + FINAL RESULT REPORTED VIBRIO NEG ACCESSION #(B)(6), RUN#1324/1326, POSITION A9/A1 & A2, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT VIBRO + AND YERSINIA + FINAL RESULT REPORTED VIBRIO NEG AND YERSINIA NEG ACCESSION #(B)(6), RUN#1344/1346, POSITION A7/B5 & B6, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT CAMPY + AND YERSINIA + FINAL RESULT REPORTED CAMPY + AND YERSINIA NEG.

    Description of Event or Problem · 0

    REPORT 1 OF 4 IT WAS REPORTED THAT BD MAX¿ ENTERIC BACTERIAL PANEL PATIENT RESULT WAS POSITIVE FOR VIBRIO ON JUNE 14 AND ON REPEAT WAS NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER NOTED THAT ONE PATIENT RESULT WAS POSITIVE FOR VIBRIO ON JUNE 14 AND REPEATED IN DUPLICATE ON JUNE 15 AND WERE NEGATIVE. ACCESSION #2316403783, RUN#1206/1209, POSITION A9/A3 & A4, ENTERIC LOT# 3088948, EXTENDED LOT# 2355384, INITIAL RESULT VIBRIO + FINAL RESULT REPORTED VIBRIO NEG ACCESSION #2321403879, RUN#1324/1326, POSITION A9/A1 & A2, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT VIBRO + AND YERSINIA + FINAL RESULT REPORTED VIBRIO NEG AND YERSINIA NEG ACCESSION #2322001055, RUN#1344/1346, POSITION A7/B5 & B6, ENTERIC LOT# 3081377, EXTENDED LOT# 3066109, INITIAL RESULT CAMPY + AND YERSINIA + FINAL RESULT REPORTED CAMPY + AND YERSINIA NEG

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995562 BD MAX¿ ENTERIC BACTERIAL PANEL GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 3088948 00382904429638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown