BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11672093 · Received April 15, 2021

    Report

    Report Number
    1119779-2021-00668
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 18, 2021
    Report Date
    June 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) UNKNOWN LOT # WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE BD MAX SYSTEM DOESN¿T RECORD THE MASTER MIX LOT NUMBER THEREFORE BD WAS UNABLE TO IDENTIFY THE BIOGX SARS-COV-2 REAGENT LOT USED. THE INVESTIGATION WAS CONDUCTED ONLY BY BD SINCE DATA ANALYSIS HAS REVEALED THAT THE BIOGX SARS-COV-2 OSR KIT WAS TESTED ALONG WITH THE EXTRACTION KIT BD MAX EXK TNA-3 LOT 1033517 AND NO BIOGX KIT LOT NUMBER WAS PROVIDED. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 LOT 1033517 INDICATED THAT LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED DISCREPANT RESULTS ON A PATIENT. A FIRST SAMPLE GAVE A POSITIVE RESULT WITH THE BD BIOGX SARS COV-2 REAGENTS BUT WHEN RECOLLECTED, THE SECOND PATIENT SAMPLE AS WELL AS REPEAT OF THE FIRST SAMPLE BOTH GAVE A NEGATIVE RESULT WITH THE BD BIOGX SARS COV-2 REAGENTS. THE SECOND SAMPLE WAS ALSO NEGATIVE WHEN TESTED WITH ANOTHER PLATFORM AS WELL AS WITH AN IGG TEST. CUSTOMER PROVIDED RUN #512 FROM INSTRUMENT CT 1420 FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS COV-2 PACKAGE INSERT INSTRUCTION FOR USE. ANALYSIS OF RUN 512 SHOWS THAT 22 SAMPLES GAVE A NEGATIVE RESULT, EXCEPT SAMPLE TESTED IN A1, WHICH GAVE A COV N1 POSITIVE/COV N2 NEGATIVE RESULT. HOWEVER, IT MUST BE NOTED THAT THE RNASEP1 WAS NEGATIVE WHEREAS RNASE P2 WAS POSITIVE, WHICH IS UNUSUAL FOR A SAME SAMPLE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS SAMPLE A1. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. ANALYSIS OF THE PCR CURVE REVEALED ATYPICAL CURVES FOR THAT SAMPLE IN BOTH CHANNELS. IN THE FAM CHANNEL IN TOP (N1 TARGET), THE SAMPLE HAD A CT OF 6.7, WHICH RESULTS IN A POSITIVE RESULT. HOWEVER, IT IS UNLIKELY THIS KIND OF CURVE WAS DUE TO TRUE AMPLIFICATION. BD WAS UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER ISSUE BUT APPEARS TO HAVE BEEN ISOLATED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT PRODUCT. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING ANOTHER MOLECULAR TEST AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. 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: " CUSTOMER PROBLEM: ONE PRESUMABLY FALSE POS RESULT FOR BIOGX ASSAY REPORTED. HOW DID YOU DETERMINE THAT THE POSITIVE RESULT WAS A FALSE ONE? THE PATIENT HAD A SECOND TEST (NEW COLLECTION, ALSO RUN ON BD MAX) ON 3/18, WHICH WAS NEGATIVE, AS WELL AS A NEGATIVE IGG TEST. RERUNS OF THE ORIGINAL SPECIMEN ON THE SAME PLATFORM AS WELL AS ANOTHER TESTING PLATFORM WERE BOTH NEGATIVE. WAS THE PATIENT SYMPTOMATIC? NO; PATIENT ORIGINALLY CAME TO BE SEEN FOR UNRELATED ISSUES. WHICH BD MAX COVID ASSAY DID YOU RUN - BIOGX OR BD ONE? BIOGX DO YOU HAVE THE REAGENTS KIT LOT NUMBER? BD KIT 1033517; BIOGX KIT UNKNOWN. WAS THE PATIENT RELEASED OR ISOLATED AND TREATED? PATIENT IS IN ISOLATION AND IS RECEIVING TREATMENT FOR COVID-19. "

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING ANOTHER MOLECULAR TEST AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. 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: CUSTOMER PROBLEM: ONE PRESUMABLY FALSE POS RESULT FOR BIOGX ASSAY REPORTED; HOW DID YOU DETERMINE THAT THE POSITIVE RESULT WAS A FALSE ONE? THE PATIENT HAD A SECOND TEST (NEW COLLECTION, ALSO RUN ON BD MAX) ON (B)(6) 2021, WHICH WAS NEGATIVE, AS WELL AS A NEGATIVE IGG TEST. RERUNS OF THE ORIGINAL SPECIMEN ON THE SAME PLATFORM AS WELL AS ANOTHER TESTING PLATFORM WERE BOTH NEGATIVE. WAS THE PATIENT SYMPTOMATIC? NO; PATIENT ORIGINALLY CAME TO BE SEEN FOR UNRELATED ISSUES. WHICH BD MAX COVID ASSAY DID YOU RUN? BIOGX OR BD ONE? BIOGX. DO YOU HAVE THE REAGENTS KIT LOT NUMBER? BD KIT 1033517; BIOGX KIT UNKNOWN. WAS THE PATIENT RELEASED OR ISOLATED AND TREATED? PATIENT IS IN ISOLATION AND IS RECEIVING TREATMENT FOR COVID-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571181 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1