BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MULTITEST CD3/CD8/CD45/CD4 CE

    MDR report key: 10460174 · Received August 27, 2020

    Report

    Report Number
    2916837-2020-00098
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 7, 2020
    Report Date
    April 13, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO MULTITEST REAGENT P/N 342417 AND TRUCOUNT PART 91-0786 AND LOT 20017. PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT OF INCORRECT ABSOLUTE COUNTS WITH CD3/8/45/4 REAGENT P/N 342417 WHEN USED WITH TRUCOUNT LOT 20017. MANUFACTURING DEFECT TREND: THERE ARE NO QN(S) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 07AUG2019 TO DATE 07AUG2020. RELATED QN(S): NONE. COMPLAINT TREND: THERE IS 1 COMPLAINT RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 07AUG2019 TO DATE 07AUG2020. RELATED COMPLAINT(S): 1737991 (THIS COMPLAINT). BATCH HISTORY RECORD (BHR) REVIEW: BHR FOR TRUCOUNT SUBCOMPONENT PART 91-0195 LOT 8355627 WAS REVIEWED. THE MATERIALS MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RETAIN SAMPLE EVALUATION / TESTING: INVESTIGATION WAS PERFORMED USING QA RETAINS OF BD MULTITEST CD3 FITC/ CD8 PE/CD45 PERCP/CD4 APC REAGENT LOT 19351 USING TRUCOUNT BEAD LOT 20017 AND MULTICHECK CONTROL LOW (BM1120L) AND NORMAL (BM1120N). RESULTS OF THE STAINING SHOWED LYMPHOCYTE COUNTS THAT FELL WITHIN THE ACCEPTABLE RANGE OF THE CONTROLS (ATTACHED ¿PR (B)(4) RETAIN TESTING TRUCOUNT AND MULTITEST.PDF¿). RETURNED SAMPLE EVALUATION: THE SAMPLES WAS NOT REQUESTED TO BE RETURNED BECAUSE FCS FILES WERE PROVIDED BY THE CUSTOMER AND WHEN ANALYZED SHOWS THAT THE P/N 342417 REAGENT HAS LOWER COUNTS THAN THE TBNK REAGENT (ATTACHED ¿PR 1737991 CUSTOMER FCS FILE ANALYSIS.XLSX¿). INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, BHR, ROOT CAUSE AND RISK ANALYSIS, THE REPORTED COMPLAINT WAS UNCONFIRMED. RISK ANALYSIS: RISK MANAGEMENT FILE PART 340334RA, REVISION A WAS REVIEWED. HAZARD(S) IDENTIFIED? YES; NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? HAZARD #: 3.2.1 INCORRECT SAMPLE VOLUME. SEVERITY: 2; PROBABILITY: 2; RISK INDEX: 4; IMPLEMENTATION: TDS & VIAL LABEL; RISK CONTROL: TDS SECTION 3 P.2 & SECTION 6 (SAMPLE PIPETTING BEST PRACTICES). NEW HAZARD: N/A. MITIGATION(S) SUFFICIENT: YES; NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? ROOT CAUSE ANALYSIS: BASED ON THE INVESTIGATION RESULT, ROOT CAUSE WAS NOT DETERMINED. CONCLUSION: BASED ON THE INVESTIGATION RESULT, COMPLAINT WAS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO INAPPROPRIATE SHIPPING TEMPERATURES ERRONEOUS RESULTS OCCURRED WITH A BD MULTITEST CD3/CD8/CD45/CD4 CE. NO IMPACT TO PATIENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RUN 6C TBNK AND MULTITEST CD3/4/8/45 ON MULTICHECK. RESULTS OBTAINED WITH 6C TBNK ARE CONFORM TO THE VALUE EXPECTED. ABSOLUTE AND RELATIVE VALUES WITH CD3/4/8/45 ARE NOT CORRECT. DONE IN DUPLICATE. THE TRUCOUNT TUBES USED FOR BOTH EXPERIMENTS ARE THE SAME. CUSTOMER CHECK ALL THE PREANALYTICAL STEPS AND WE CAN EXCLUDE MANIPULATION ISSUE.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO INAPPROPRIATE SHIPPING TEMPERATURES ERRONEOUS RESULTS OCCURRED WITH A BD MULTITEST CD3/CD8/CD45/CD4 CE. NO IMPACT TO PATIENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RUN 6C TBNK AND MULTITEST CD3/4/8/45 ON MULTICHECK. RESULTS OBTAINED WITH 6C TBNK ARE CONFORM TO THE VALUE EXPECTED. ABSOLUTE AND RELATIVE VALUES WITH CD3/4/8/45 ARE NOT CORRECT. DONE IN DUPLICATE. THE TRUCOUNT TUBES USED FOR BOTH EXPERIMENTS ARE THE SAME. CUSTOMER CHECK ALL THE PREANALYTICAL STEPS AND WE CAN EXCLUDE MANIPULATION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928180 BD MULTITEST CD3/CD8/CD45/CD4 CE NA GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other