BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX EXK DNA-3

    MDR report key: 12052005 · Received June 23, 2021

    Report

    Report Number
    3007420875-2021-00024
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 26, 2021
    Report Date
    August 17, 2021
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    JJH
    UDI-DI
    00382904428211
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: SEE H.10. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1033586. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-07-30. H.4. DEVICE MANUFACTURE DATE: 2021-02-02. D.4. MEDICAL DEVICE LOT #: 1103395. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-09-17 . H.4. DEVICE MANUFACTURE DATE: 2021-04-13.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR CONTAMINATION WHEN USING BD MAX EXK DNA-3 KIT (REF #442821) FROM LOT 1033586 AND 1103395 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, ANALYSIS OF CUSTOMER DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX EXK DNA-3 KIT LOTS INDICATED THAT THE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. MATERIAL WAS RECEIVED FROM THE CUSTOMER (22 KITS OF LOT 1103395) HOWEVER THE RETURNED MATERIAL WAS NOT TESTED. TESTING THE RETURNED MATERIAL FOR THIS KIT WOULD NOT PROVIDE MORE INFORMATION ON THE CAUSE OF THE CUSTOMER ISSUE. THE CUSTOMER IS USING A KIT FROM ANOTHER PROVIDER (BIOGX), WHICH CONTAINS THE PRIMERS AND PROBES SPECIFIC TO THE CUSTOMER¿S TARGETS. THE CUSTOMER ALLEGES THAT THE BD MAX¿ EXK¿ DNA-3 KITS ARE THE SOURCE OF THE E. FAECALIS IN THEIR TEST RESULTS. THE DATABASE OF INSTRUMENT CT2222 WAS ANALYZED AND CONTAINS 175 SAMPLES TESTED WITH A BIOGX TEST WHICH IS USED TO DETECT THE E. FAECALIS TARGET IN URINE SAMPLE. A TOTAL OF THREE LOTS WERE USED, LOTS 1033586 AND 1103395 INCLUDED IN THE PRESENT COMPLAINT, AS WELL AS LOT 1131462. THE FIRST TWO LOTS OBTAINED A 100% POSITIVITY RATE FOR THE E. FAECALIS TARGET, WHEREAS LOT 1131462 (LAST LOT USED) OBTAINED A 17.9% POSITIVE RATE. ANALYSIS OF THE CUSTOMER DATA REVEALED MULTIPLE UDP MODIFICATIONS PERFORMED IN TIME, TO DISCRIMINATE BETWEEN LATE POSITIVES RESULTS WHICH COULD BE DUE TO NONSPECIFIC AMPLIFICATION, AND TRUE POSITIVES RESULTS. THESE UDP SETTING CHANGES PARTLY EXPLAIN WHY THE POSITIVITY RATE DECREASES WITH LOT 1131462. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON THE VALIDATION RUNS (RUNS 46 AND 47) AND IT WAS FOUND THAT 97.1% OF THE SAMPLES TESTED IN THOSE RUNS GOT A SIGNAL INCREASE OF THE E. FAECALIS TARGET (FAM CHANNEL, BOTTOM POSITION) SUGGESTING THAT THE ISSUE IS NOT RECENT AND WAS PRESENT SINCE THE VALIDATION OF THIS TEST. IT IS POSSIBLE THAT THE CUSTOMER WAS NOT AWARE OF THESE SIGNAL INCREASES SINCE NO RESULTS STATUS WERE SET AT THIS TIME IN THEIR UDP DURING ASSAY VALIDATION. HOWEVER, THE ANALYSIS INDICATES THAT THESE VALIDATION SAMPLES WOULD HAVE OBTAINED A POSITIVE RESULT. AS FOR THE LOT 1131462, THE SAME TYPE OF PCR SIGNAL INCREASE WAS ALSO OBSERVED IN ALL THE SAMPLES TESTED, BUT WITH LESS OCCURRENCES. MULTIPLE ADJUSTMENT IN THE UDP SETTINGS WERE PERFORMED SINCE THE VALIDATION TESTS AND THE MOST RECENT CHANGES INCLUDED THE ADDITION OF A CT CUTOFF OF 36. THIS CHANGE COULD EXPLAIN WHY THE MOST RECENT SAMPLES TESTED WITH LOT 1131462 OBTAINED A LOWER POSITIVITY RATE THAN THE TWO OTHER LOTS. ALSO, THE ANALYSIS REVEALED THE SAME INCREASES IN ALL THE TYPES OF SAMPLES TESTED (QC, BLANK AND PATIENT SAMPLES). THE FACT THAT THIS AMPLIFICATION IS PRESENT IN MANY SAMPLES, AND PRESENTED A SIMILAR ASPECT EVERY TIME, SUGGESTS THAT THE AMPLIFICATION OBSERVED IS NOT SPECIFIC. MANUFACTURING OF BD MAX¿ ASSAYS IS CONDUCTED IN CLEANROOMS TO PREVENT CONTAMINATION OF THE KIT'S COMPONENTS DURING THE MANUFACTURING PROCESS. AS SUCH, IT IS VERY UNLIKELY THAT THE POSITIVE RESULTS OBTAINED BY THE CUSTOMER IS COMING FROM A LIVE ORGANISM CONTAMINATION DURING PRODUCTION. A RAW MATERIAL ANALYSIS WAS PERFORMED ON SEVERAL BD MAX¿ EXK¿ DNA-3 AND DNA-1 KIT LOTS AND NO LINK WITH ANY RAW MATERIAL LOT WAS IDENTIFIED WHICH COULD HAVE EXPLAINED THE RESULTS OBTAINED BY THE CUSTOMER. OVERALL, CONSIDERING THAT MULTIPLE KIT LOTS, AS WELL AS MULTIPLE TYPES OF BD MAX¿ EXK¿ DNA ASSAYS KITS AND TYPES OF SAMPLES PROCESSED ALL SHOWED THIS INCREASE IN THE FAM CHANNEL (E. FAECALIS TARGET), THIS SUGGESTS AMPLIFICATION IS NOT SPECIFIC TO THE SAMPLES NOR RELATED TO SPECIFIC LOTS OF REAGENTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR CONTAMINATION FOR THE BD MAX EXK DNA-3 KIT LOT 1033586 AND 1103395. BASED ON THE AVAILABLE INFORMATION, BD WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER ISSUE. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 25 BD MAX¿ EXK¿ DNA-3 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER ALLEGES THE KITS BEING A SOURCE OF E. FAECALIS CONTAMINATION OF THEIR RUNS"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 25 BD MAX¿ EXK¿ DNA-3 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ALLEGES THE KITS BEING A SOURCE OF E. FAECALIS CONTAMINATION OF THEIR RUNS."

    Additional Manufacturer Narrative · 1

    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 THAT WHILE USING 25 BD MAX¿ EXK¿ DNA-3 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER ALLEGES THE KITS BEING A SOURCE OF E. FAECALIS CONTAMINATION OF THEIR RUNS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946043 BD MAX EXK DNA-3 CLINICAL SAMPLE CONCENTRATOR JJH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 442821 SEE H.10. 00382904428211

    Patients

    Seq Age Sex Outcome Treatment
    1