BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ ENTERIC PARASITE PANEL

    MDR report key: 13929987 · Received March 28, 2022

    Report

    Report Number
    3007420875-2022-00011
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 10, 2022
    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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR ATYPICAL CURVES WITH THE KIT BD MAX¿ ENTERIC PARASITE PANEL (REF 442960) LOT 1103407 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ ENTERIC PARASITE PANEL INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. CUSTOMER COMPLAINED ABOUT ATYPICAL CURVES THAT GAVE POSITIVE RESULTS WITH THE BD MAX¿ ENTERIC PARASITE PANEL (REF#442960) KIT LOT 1103407. CUSTOMER PROVIDED TWO RUNS FILE ((B)(4)) AND DATABASE FROM INSTRUMENT CT2261 FOR INVESTIGATION. ANALYSIS OF THE DATABASE REVEALED POSITIVE RESULTS FOR THE CRYPTO TARGET IN POSITIONS A1 AND A5 OF RUN (B)(4) AND POSITIONS A1, A2, A3, A4, A5 AND A7 OF RUN (B)(4), AS WELL AS POSITIVE RESULTS FOR THE GLAMB TARGET IN POSITIONS A1, A2 AND A3 OF RUN (B)(4), ALL ASSOCIATED TO UNUSUAL PCR CURVES THAT SUGGESTS THESE POSITIVE RESULTS ARE NOT TRUE AMPLIFICATIONS. REVIEW OF THE COMPLAINT DATABASE BY BD REVEALED THAT AN INSTRUMENT COMPLAINT WAS OPENED TO ASSESS THESE ATYPICAL CURVES. BASED ON THE CURRENT INVESTIGATION AND CURVES REVIEW, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR ATYPICAL CURVES ON BD MAX¿ ENTERIC PARASITE PANEL KIT LOT 1103407. THE ROOT CAUSE IS STRONGLY SUSPECTED TO BE AN INSTRUMENT ISSUE. THE REAGENTS ARE NOT SUSPECTED OF BEING IN CAUSE. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL ON BD MAX¿ SYSTEM, A FALSE POSITIVE RESULT WAS OBTAINED. RESULTS WERE DEEMED UNRELIABLE WITHOUT CONFIRMATORY TESTING. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "VERY WEIRD CURVES CALLED POSITIVE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL ON BD MAX¿ SYSTEM, A FALSE POSITIVE RESULT WAS OBTAINED. RESULTS WERE DEEMED UNRELIABLE WITHOUT CONFIRMATORY TESTING. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "VERY WEIRD CURVES CALLED POSITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298531 BD MAX¿ ENTERIC PARASITE PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 442960 1103407 00382904429607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown