BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ONEFLOW ALOT

    MDR report key: 11457346 · Received March 10, 2021

    Report

    Report Number
    2916837-2021-00079
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. SCOPE OF ISSUE: THE SCOPE OF THE ISSUES IS LIMITED TO PN 660228 LN 0094371, IVD. PROBLEM STATEMENT: CUSTOMER REPORTED A FALSE POSITIVE COMPLAINT ON 2-11-2021. STRONG CD7-APC SIGNALS ACTUALLY "SPILLS?/AUTOFLUORESCENCE?" INTO THE CYCD3-V450 CHANNELS AND MAKE IT AS A STRONG POS AS WELL. BUT THE T-ALL TUBE 1 RESULT ACTUALLY SHOWING THAT MAJORITY OF THE POI IS HAVING CYCD3-. MANUFACTURING DEFECT TREND: THERE ARE 0 QN¿S RELATED TO THE REPORTED ISSUE. DATE RANGE 02/11/2021 TO 02/11/2020. ROOT CAUSE ANALYSIS: BASED ON THE INVESTIGATION RESULT THE ROOT CAUSE WAS NOT DETERMINED. COMPLAINT HISTORY REVIEW: THERE ARE 4 COMPLAINTS REPORTED COMPLAINT. DATE RANGE FROM 2-11-2021 TO 02/11/2020. RISK REVIEW BD ONEFLOW ALOT RISK ANALYSIS, VERSION B, DOC# 10000241669 WAS REVIEWED. HAZARD(S) IDENTIFIED? ¿YES ¿ NO IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? HAZARD #: 3.2.20. HAZARD: INDIRECT HARM TO PATIENT. CAUSE: TOO LONG OF STAIN TIME RESULTS IN DRAG-UP REQUIRING RE-STAIN OF SPECIMEN. HARMFUL EFFECTS: DELAY OF RESULTS. SEVERITY: 2. PROBABILITY: 3. RISK INDEX: 6. IMPLEMENTATION: BD ONEFLOW ALOT IFU, SECTION 9. PROCEDURE. RISK CONTROL: IFU TO STATE PROPER STAIN TIME. EFM-DID-13709 AND 13710 . EFFECTIVENESS VERIFICATION: LABELLING APPROVAL. MITIGATION(S) SUFFICIENT YES . IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? HAZARD(S) IDENTIFIED? ¿YES ¿ NO IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? HAZARD #: 3.2.31. HAZARD: INDIRECT HARM TO PATIENT. CAUSE: REAGENT FAILURE BASED ON PER TUBE FAILURE NOT DETECTED DUE TO NO ASSAY SPECIFIC QC CONTROL PROVIDED FROM BD. HARMFUL EFFECTS: INCORRECT RESULTS. SEVERITY: 2. PROBABILITY: 3. RISK INDEX: 6. IMPLEMENTATION: BD ONEFLOW ALOT IFU, SECTIONS 1, 9 AND 11. BD ONEFLOW APPLICATION GUIDE FOR A LOT. THE PLOTS SHOWING IN THE FIGURES OF THE ALOT ANALYSIS GLOBAL WORKSHEET ARE FOR NORMAL POPULATION OF CELLS. RISK CONTROL: OTHER TEST RESULTS IN CONJUNCTION WITH THIS TEST REQUIRED FOR DIAGNOSIS OF DISEASE STATE. BECAUSE ALL SAMPLES WITH ABNORMAL AND CELLS ALSO HAVE NORMAL CELLS. THOSE NORMAL CELLS CAN BE COMPARED AGAINST THE NORMAL DATABASE AND USED AS A PROCESS CONTROL. IFU INSTRUCTS USER TO CHECK RESIDUAL NORMAL CELLS STAINING PATTERN. EFFECTIVENESS VERIFICATION: NA . MITIGATION(S) SUFFICIENT YES IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? BATCH HISTORY RECORD (BHR) REVIEW: THE FOLLOWING BATCH RECORDS WERE REVIEWED. 660228-0094371 ONEFLOW ALOT. 91-0996-0070593 POUCH ONEFLOW ALOT-S. 91-1006-0070597 POUCH ONEFLOW ALOT-C. 60-0799-0051976 REAGENT ONEFLOW ALOT-S. 60-0811-0064775 REAGENT ONEFLOW ALOT-C. THE MATERIALS MET ALL THE MANUFACTURING SPECIFICATION PRIOR TO RELEASE. RETURNED SAMPLE ANALYSIS: THE SAMPLE WAS NOT REQUESTED TO BE RETURNED. A PHOTO OF A BD ALOT REAGENT AND A PHOTO OF T-ALL (CUSTOMER¿S PANEL) REAGENT STAINED PATIENT SPECIMEN WERE PROVIDED BY THE CUSTOMER. THE ALOT REAGENT STAINED SAMPLE SHOWED THE CD45DIM POPULATION TO BE BRIGHT CD7+ APC AND SPILLED OVER TO CYCD3 V450 CHANNEL AND RESULTED A CYCD3+ RESULTS. THE T-ALL STAINED SAMPLE SHOWED THAT NOT ALL OF THE CD45DIM POPULATION WERE CYCD3+. HENCE, THE CUSTOMER COMPLAINT FOR A FALSE POSITIVE RESULTS. RETAIN SAMPLE ANALYSIS: PERIPHERAL BLOOD SAMPLE FROM A NORMAL DONOR WAS STAINED WITH THE RETAIN SAMPLE OF BD ONEFLOW ALOT (660228-0094371) REAGENT AND ACQUIRED IN CANTO II INSTRUMENT. CD7 APC / CYCD3 V450 DOT PLOT DID NOT SHOW ANY SPILLOVER OF THE CD7+ NK CELLS TO THE V450 REGION. MFI RESULTS OF THE MARKERS IN THE REAGENT MET ALL THE ESTABLISHED MFI ACCEPTANCE CRITERIA AND PERFORMED AS EXPECTED WHEN USED TO STAIN NORMAL BLOOD SPECIMEN. THE OBSERVATION REPORTED BY THE CUSTOMER WAS NOT CONFIRMED DUE TO THE UNAVAILABILITY OF THE APPROPRIATE PATIENT SAMPLE TO DUPLICATE THE ISSUE. CONCLUSION: BASED ON THE INVESTIGATION RESULT: THE COMPLAINT WAS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ONEFLOW¿ ALOT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "CS&T IVD BEADS 50 TEST FALSE POSITIVE. STRONG CD7-APC SIGNALS ACTUALLY "SPILLS?/AUTOFLUORESCENCE?" INTO THE CYCD3-V450 CHANNELS AND MAKE IT AS A STRONG POS AS WELL. BUT THE T-ALL TUBE 1 RESULT ACTUALLY SHOWING THAT MAJORITY OF THE POI IS HAVING CYCD3-." THESE PRODUCTS ARE USED FOR CLINICAL USE, ON PATIENT SAMPLE. IN THIS CASE, WE ABLE TO DETECT IT EARLIER AND USE FEATURE ' MANUAL COMPENSATION' TO CORRECT THE ? FALSE +VE BEFORE THE PATIENT DIAGNOSIS AND RESULT RELEASE." STRONG CD7-APC SIGNALS ACTUALLY "SPILLS?/AUTOFLUORESCENCE?" INTO THE CYCD3-V450 CHANNELS AND MAKE IT AS A STRONG POS AS WELL. BUT THE T-ALL TUBE 1 RESULT ACTUALLY SHOWING THAT MAJORITY OF THE POI IS HAVING CYCD3-.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD ONEFLOW¿ ALOT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "CS&T IVD BEADS 50 TEST FALSE POSITIVE. STRONG CD7-APC SIGNALS. ACTUALLY "SPILLS?/AUTOFLUORESCENCE?" INTO THE CYCD3-V450 CHANNELS AND MAKE IT AS A STRONG POS AS WELL. BUT THE T-ALL TUBE 1 RESULT ACTUALLY SHOWING THAT MAJORITY OF THE POI IS HAVING CYCD3-." THESE PRODUCTS ARE USED FOR CLINICAL USE, ON PATIENT SAMPLE. IN THIS CASE, WE ABLE TO DETECT IT EARLIER AND USE FEATURE ' MANUAL COMPENSATION' TO CORRECT THE ? FALSE +VE BEFORE THE PATIENT DIAGNOSIS AND RESULT RELEASE." STRONG CD7-APC SIGNALS ACTUALLY "SPILLS?/AUTOFLUORESCENCE?" INTO THE CYCD3-V450 CHANNELS AND MAKE IT AS A STRONG POS AS WELL. BUT THE T-ALL TUBE 1 RESULT ACTUALLY SHOWING THAT MAJORITY OF THE POI IS HAVING CYCD3-.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354563 BD ONEFLOW ALOT NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 0094371

    Patients

    Seq Age Sex Outcome Treatment
    1