BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX ENTERIC VIRAL PANEL

    MDR report key: 15528712 · Received October 3, 2022

    Report

    Report Number
    1119779-2022-01257
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 5, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    PCH
    PMA / PMN Number
    K181427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE KIT BD MAX ENTERIC VIRAL PANEL CATALOG NUMBER 443985 WITH 510K # K181427. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT # 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL THE USER TESTED NORO/ROTO RING TRIAL AND FAILED IN NOROVIRUS GENOTYPE I DETECTION, EVEN THOUGH THE ASSAY SHOULD DETECT G I/II. PATIENTS WERE INVOLVED BUT THERE'S NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER TESTED NORO/ROTO RING TRIAL AND FAILED IN NOROVIRUS GENOTYPE I DETECTION, EVEN THOUGH THE ASSAY SHOULD DETECT G I/II.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL THE USER TESTED NORO/ROTO RING TRIAL AND FAILED IN NOROVIRUS GENOTYPE I DETECTION, EVEN THOUGH THE ASSAY SHOULD DETECT G I/II. PATIENTS WERE INVOLVED BUT THERE'S NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER TESTED NORO/ROTO RING TRIAL AND FAILED IN NOROVIRUS GENOTYPE I DETECTION, EVEN THOUGH THE ASSAY SHOULD DETECT G I/II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337267 KIT BD MAX ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown