BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ EXK¿ TNA-3

    MDR report key: 13388655 · Received January 28, 2022

    Report

    Report Number
    1119779-2022-00151
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 21, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JJH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 1033517 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT #. 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

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD MAX¿ EXK¿ TNA-3 KIT (REF. 442827) LOT 1033517 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX¿ EXK¿ TNA-3 KIT INDICATED THAT LOT 1033517 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED TWO DISCREPANT AND ONE FALSE POSITIVE RESULT ON A NEGATIVE CONTROL, WITH BIOGX SARS-COV-2 ASSAY USED IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 KIT LOT #1033517 EXTRACTION KIT. THE SAMPLES WERE POSITIVE FOR THE INITIAL RESULT BUT NEGATIVE UPON REPEAT. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION FROM THE CUSTOMER, NO DATA WAS PROVIDED FOR THE INVESTIGATION. WITHOUT MORE INFORMATION, BD WAS UNABLE TO INVESTIGATE FURTHER, AND THE CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. OVERALL, BASED ON THE INVESTIGATION, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ EXK¿ TNA-3 KIT LOT 1033517. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: D.1. BRAND NAME: BD MAX¿ EXK¿ TNA-3; D.2. COMMON DEVICE NAME: CLINICAL SAMPLE CONCENTRATOR; JHH. D.4. CATALOG NUMBER: 442827; UDI NUMBER: (B)(4); LOT NUMBER: 1033517; EXPIRATION DATE: 2022-07-26. H.4. CREATION DATE: 2021-02-02.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA200098 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " BIOGX SARS COV2 DISCREPANT RESULTS. INITIAL RESULTS ARE POSITIVE AND THEN NEGATIVE UPON REPEAT ON MAX. "

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BIOGX SARS COV2 DISCREPANT RESULTS. INITIAL RESULTS ARE POSITIVE AND THEN NEGATIVE UPON REPEAT ON MAX.."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA(B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " BIOGX SARS COV2 DISCREPANT RESULTS. INITIAL RESULTS ARE POSITIVE AND THEN NEGATIVE UPON REPEAT ON MAX. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640880 BD MAX¿ EXK¿ TNA-3 CLINICAL SAMPLE CONCENTRATOR JJH BECTON, DICKINSON & CO. (SPARKS) 1033517
    847763 BD MAX¿ EXK¿ TNA-3 CLINICAL SAMPLE CONCENTRATOR JJH BECTON, DICKINSON & CO. (SPARKS) 1033517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown