BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 12516046 · Received September 22, 2021

    Report

    Report Number
    1119779-2021-01556
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 23, 2021
    Report Date
    November 5, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 FOR BD MAX SYSTEM (REF (B)(4)) UNKNOWN LOT NUMBER IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 LOT # 1005356. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 INDICATED THAT LOTS #1005356 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE KIT LOT NUMBER PROVIDED (K21-250) IN THE COMPLAINT TEXT, DOES NOT CORRESPOND TO A LOT NUMBER FOR BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM. THIS IS A LOT NUMBER FOR BIOGX SARS-COV-2 RNA CONTROLS (REF. (B)(4)). THEREFORE, BIOGX HAS PERFORM THE MANUFACTURING RECORD REVIEW OF BIOGX SARS-COV-2 RNA CONTROLS LOT K21-250 AND DID NOT INDICATE ANY ISSUES AND MEET CRITERIA FOR RELEASE. CUSTOMER REPORTED DISCREPANT RESULTS ON 2 SAMPLES WHEN USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM FROM UNKNOWN LOT NUMBER, USED IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 KIT LOT 1005356. THE TWO SAMPLES GAVE A POSITIVE RESULT INITIALLY, BUT ONE OF THEM WAS NEGATIVE UPON REPEAT, WHILE THE OTHER WAS NOT RETESTED. ASIDE FROM THE INFORMATION AVAILABLE IN THE COMPLAINT TEXT, NO DATA WAS RECEIVED FROM THE CUSTOMER. THE COMPLAINT TEXT MENTIONED THAT CUSTOMER PERFORMED ENVIRONMENTAL RUN AND A POSITIVE RESULT WAS OBTAINED. THEREFORE, A CONTAMINATION ISSUE COULD BE RESPONSIBLE FOR THE POSITIVE RESULTS. HOWEVER, NO DATA WAS RECEIVED FOR ANALYSIS AND THE INVESTIGATION WAS LIMITED. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BIOGX SARS-COV-2 FOR BD MAX SYSTEM PRODUCT. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BIOGX AND BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA).

    Additional Manufacturer Narrative · 0

    THE REPORTED LOT # K21-250 WAS NOT FOUND FOR THE REPORTED CATALOG # 444213. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2, 2 FALSE POSITIVE RESULTS WERE OBTAINED ON THE BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE NEGATIVE. THE FALSE POSITIVES WERE REPORTED TO THE CLINICIANS, BUT THE CONFIRMATORY TESTING RESULTS WERE NOT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: DISCREPANT RESULTS; BIOGX SARS COV2 SAMPLE#1: INITIAL RUN# 205-A11; POSITIVE N1 AND N2. REPEAT RUN# 208-A2; NEGATIVE. RECOLLECTED RUN# 207-B8; NEGATIVE. SAMPLE#2: RUN#208-A6 POSITIVE FOR N2. NO REPEATS" SAMPLES AFFECTED (PATIENT OR EXTERNAL CONTROL): PATIENT ONLY FINAL RESULTS REPORTED TO CLINICIAN: SAMPLE#1: CUSTOMER REPORTED POSITIVE RESULTS SAMPLE#2: NONE ADVERSE EFFECT ON PATIENT, IF ANY: NONE TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: NONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2, 2 FALSE POSITIVE RESULTS WERE OBTAINED ON THE BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE NEGATIVE. THE FALSE POSITIVES WERE REPORTED TO THE CLINICIANS, BUT THE CONFIRMATORY TESTING RESULTS WERE NOT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: DISCREPANT RESULTS; BIOGX SARS COV2. (B)(6). SAMPLES AFFECTED (PATIENT OR EXTERNAL CONTROL): PATIENT ONLY. FINAL RESULTS REPORTED TO CLINICIAN: SAMPLE#(B)(6): CUSTOMER REPORTED POSITIVE RESULTS. SAMPLE#(B)(6): NONE. ADVERSE EFFECT ON PATIENT, IF ANY: NONE. TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414204 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown