BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC PARASITE PANEL

    MDR report key: 17628221 · Received August 25, 2023

    Report

    Report Number
    3007420875-2023-00082
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    July 12, 2023
    Report Date
    September 20, 2023
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904429607
    PMA / PMN Number
    K143648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 3007420875-2023-00082 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PREFIX: (B)(6). H3: 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 REPORTE THAT WHILE USING BD MAX¿ ENTERIC PARASITE PANEL, THERE WAS ONE FALSE NEGATIVE RESULT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED CONTRASTING RESULTS FOR CRYPTOSPORIDIUM USING BD MAX (NEGATIVE) COMPARED WITH TWO INDEPENDENT METHODS: QIAGEN (POSITIVE CT 37) AND AN IN-HOUSE METHOD (POSITIVE CT 33). WHEN DID THE INCIDENT OCCUR? AFTER USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC PARASITE PANEL, THERE WAS ONE FALSE NEGATIVE RESULT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED CONTRASTING RESULTS FOR CRYPTOSPORIDIUM USING BD MAX (NEGATIVE) COMPARED WITH TWO INDEPENDENT METHODS: QIAGEN (POSITIVE CT 37) AND AN IN-HOUSE METHOD (POSITIVE CT 33). WHEN DID THE INCIDENT OCCUR? AFTER USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889397 BD MAX¿ ENTERIC PARASITE PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 2285864 00382904429607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown