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	05/12/2022
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.
Event or Problem Description
It was reported that bd trucount¿ tubes acquired erroneous results on patient samples.The following information was provided by the initial reporter: "discrepancy between counts done with trucount tubes lot 1348535 and 2 other lots customer compared counting with lot 1348535 to 2 other lots of trucount tubes.Counting with lot 1348535 gives different results than 2 other lots and cellular counter.Other reagents used are the same.Lots are tested in parallel on same sample.Please find the answers of the customer 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) no.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) no.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) no.5.Provide details - how and to what extent? (go to question #6) n/a.6.What is the current medical status? (no further questions required.) n/a".
Event or Problem Description
It was reported that bd trucount¿ tubes acquired erroneous results on patient samples.The following information was provided by the initial reporter: "discrepancy between counts done with trucount tubes lot 1348535 and 2 other lots.Customer compared counting with lot 1348535 to 2 other lots of trucount tubes.Counting with lot 1348535 gives different results than 2 other lots and cellular counter.Other reagents used are the same.Lots are tested in parallel on same sample.Please find the answers of the customer 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) no.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4) no.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) no.5.Provide details - how and to what extent? (go to question #6) n/a.6.What is the current medical status? (no further questions required.) n/a".
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.9.Device available for eval? yes.D.9 returned to manufacturer on: 13-may-2022.H.2 device return to manuf? no.H.2 device eval by manufacturer? yes.Investigation summary: problem statement: customer reported a complaint that the product gave discrepant absolute counts compared to another method on (b)(6) 2022.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 six other complaints related to the reported issue in addition to this complaint # (b)(4) from (b)(6) 2021.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: trucount lots retain testing 2022-06-06 returned sample evaluation: the sample was not available.Risk review: risk analysis, trucount tubes, #10000490283, rev.03, was reviewed.Hazard(s) identified? yes hazard id#: 3.2.4.Hazard: use error hazard.Cause: improper gating of bead population by the user.Harmful effects: aberrant bead results.Severity: 2.Probability: 2.Risk index: 4.Implementation: tds.Risk control: customer education program.Effectiveness verification: tds instruction for flow cytometry page 4.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.

• 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: 14548941
• Report Number: 2916837-2022-00140
• Device Sequence Number: 15147286
• 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): 08/10/2022

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 Expiration Date: 10/31/2023
• Device Model Number: 663028
• Device Catalogue Number: 663028
• Device Lot Number: 1348535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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