MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD TRUCOUNT¿ TUBES; COUNTER, DIFFERENTIAL CELL

Model Number	663028
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd trucount¿ tubes produced erroneous results on patient samples.The following information was provided by the initial reporter: "the customer report a defective trucount lot (21280).These trucount tube allow the numeration of leukocyte population in cytometry.This defective lot leads to bias in the numeration of leukocyte population in blood and in bone marrow, which could impair the accuracy of the diagnostic.They ask us to quickly replace their current defective lot by a new lot (ideally 22020).The bias in the numeration could impact the diagnostic.Please find answers below: are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) - yes.Was there any delay of treatment due to the issue? (go to question #3) - there was for sure a delay in the diagnosis, but i am not sure that this was responsible for a delay in the treatment, since the customer is competent and since she called us as soon as the issue was characterized.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) - i don¿t know.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required) - not that i am aware of, which means ¿no¿, since the customer didn¿t tell me so.Provide details - how and to what extent? (go to question #6).What is the current medical status? (no further questions required.)- i don¿t understand this question".
Additional Manufacturer Narrative
H.6 investigation summary: investigation summary: ¿ problem statement: customer reported a complaint that the product gave discrepant absolute counts compared to another method on 20may2022.¿ scope.The scope of issue is limited to part 663028 and lot 1348535 containing sub-component part 91-0786 lot 21280 and 91-0195-1144744.¿ manufacturing defect trend: there were no product non-conformities in the production and testing of part 663028 and lot 1348535.¿ complaint trend: there were eight other complaints related to the reported issue in addition to this complaint #5235576 from 20may2021 to 20may2022.Additional complaints: #4622948; #491171; 4948705; #5074256; 5086940; 5179372; 5179392; 5236081.¿ batch history record (bhr) review: ¿ bhr part 91-0195-1144744 was reviewed.The materials met all the manufacturing specifications prior to release.¿ retain sample evaluation / testing: ¿ the retain sample part 91-0786 lot 21280 was tested and evaluated using tbnk reagent and multicheck control cells and acquired on facscanto ii.Results indicate that the trucount beads are performing correctly.Absolute counts of major populations of lymphocytes fell within the specified multicheck control ranges.However, there was an observed bias of ~+8% when compared to three other lots of trucount.This is below the allowable 10% variation due to counting statistics.¿ the investigation was performed and based on the review of complaint trend, defect trend, bhr, root cause and risk analysis, the reported complaint was not confirmed.¿ retain testing analysis file name (attached): trucount lots retain testing 2022-06-06.¿ returned sample evaluation: the sample was not requested as bd keeps retains.¿ risk review: 0 risk analysis, trucount tubes, #10000490283, rev.03, was reviewed.Hazard(s) identified? yes.Hazard id#: 3.1.3.Hazard: functional hazard.Cause: number of beads in the pellet vary from tube to tube.Harmful effects: inaccurate results.Severity: 5.Probability: 3.Risk index: 15.Implementation: (b)(6).Risk control: acceptance criteria for the bead pellets will be tight enough to prevent the number of beads pellets to vary greatly from tube to tube.Effectiveness verification: eco release of ms and qc documents.New hazard: n/a.Mitigation(s) sufficient? yes.¿ root cause analysis: based on the investigation result, root cause was not determined.¿ investigation conclusion: based on the investigation result, complaint was unconfirmed.
Event or Problem Description
It was reported that bd trucount¿ tubes produced erroneous results on patient samples.The following information was provided by the initial reporter: "the costumer report a defective trucount lot (21280).These trucount tube allow the numeration of leukocyte population in cytometry.This defective lot leads to bias in the numeration of leukocyte population in blood and in bone marrow, which could impair the accuracy of the diagnostic.They ask us to quickly replace their current defective lot by a new lot (ideally 22020).The bias in the numeration could impact the diagnostic.Please find answers below: 1.Are there erroneous results on patient samples for diagnostic test? (if yes, go to question #2, if no, no further questions required.) - yes.2.Was there any delay of treatment due to the issue? (go to question #3) - there was for sure a delay in the diagnosis, but i am not sure that this was responsible for a delay in the treatment, since the customer is competent and since she called us as soon as the issue was characterized.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) - i don¿t know.4.Was there any physical harm/injury to the patient due to the issue? (if yes, go to question #5.If no, no further questions required) - not that i am aware of, which means ¿no¿, since the customer didn¿t tell me so.5.Provide details - how and to what extent? (go to question #6) 6.What is the current medical status? (no further questions required.)- i don¿t understand this question.".

• Brand Name: BD TRUCOUNT¿ TUBES
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14489985
• Report Number: 2916837-2022-00133
• Device Sequence Number: 20167640
• Product Code: GKZ
• UDI-Device Identifier: 00382906630285
• UDI-Public: 00382906630285
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 663028
• Device Catalogue Number: 663028
• Device Lot Number: 21280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown