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

Model Number	340334
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	03/20/2023
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 while using the bd trucount¿ tubes that there was erroneous results.The following information was provided by the initial reporter: according to the customer's report, subpopulations are seen in addition to the bead body population when measuring beads.
Additional Manufacturer Narrative
H.6 scope of issue: the scope of issue is limited to part 340334, trucount absolute counting tubes us ivd, lot 2237014.Problem statement: customer reported complaint on 03/22/2023 that subpopulations are seen in addition to the bead body population when measuring beads.Investigation summary: this investigation includes evaluation for material 340334, lot 2237014, and its subassembly component 91-0786, lot 22046.Manufacturing defect trend: there are none qn(s) containing the same or similar reported issue for 340334 or subassembly part 91-0786.Date range from 22mar2022 to date 22mar2023.Related qn(s) number____n/a__________ device history record (dhr) review or batch history record (bhr) review: bhr for part #340334, lot 2237014 and 91-0786, lot 22046 were reviewed.Total production of 91-0786, lot 22046 was 29,865 pouches, each containing 25 tubes (total of (b)(4) tubes).The product met all the manufacturing specifications prior to release.No deviations were found in the process.Complaint history review: the complaint history evaluation was performed for material 340334, lot 2237014 and other products manufactured using subassembly 91-0786, lot 22046, refer to table 1 below: table 1.Where-used 91-0786/22046 material # lot # qty 663028 2095615 2400 340334 2108676 2400 340334 2101458 2400 340334 2095186 2400 342447 33863 1920 342447 80232 1920 342444 73302 976 337166 89150 759 342444 80204 720 344563 2124891 1034 340334 2237014 368 662415 2195942 349 338331 2213297 134 338331 2201159 64 664231 2237039 53 340498 2199410 35 342446 74245 240 342446 74250 240 there is only one complaint related to the reported complaint defect; pr# (b)(4) ¿ this complaint.Date range from 22mar2022 to date 22mar2023.Retain sample analysis: the retain sample part 340334 and lot 2237014 was tested and evaluated.The evaluation was conducted by staining multi-check control sample with tbnk reagent in trucount tubes (340334-2237014).Five representative tubes were tested.Staining was done according to the ifu and acquired in canto ii instrument clinical software.Results showed that product 340334, lot 2237014 is performing as intended.No abnormalities were observed.Refer to attached files for retain sample testing.Returned sample analysis: the complaint sample was not requested to be returned because photo(s) / picture(s) was provided.The photo(s) / picture(s) was evaluated, and show the defect that the customer is claiming.Risk review: risk management file part #10000490283, ra bd trucount tubes, rev.03 was reviewed.Hazard(s) identified / end user risk (ruo products only)? yes hazard id# / end user risk (ruo products only): 3.2.7 hazard / end user risk (ruo products only): use error hazard cause: contamination or accidental ingress of foreign material into trucount tube by user harmful effects: innacurate results residual severity: 3 residual probability: 1 residual risk index: 3 potential cause(s): based on the investigation results, the potential cause(s) was determined to be an introduction of foreign material into the sample, based on the product risk analysis and retain sample results.Investigation result / analysis: the investigation was performed and based on the review of complaint trend (1 complaint - this complaint), defect trend, bhr review and risk analysis, the potential cause of the subpopulation observed in trucount absolute counting tubes was due to a potential introduction of foreign matter by the user.Retain sample of material 340334, lot 2237014 was tested.Evaluation of the results showed that the material was performing as intended and no anomalies were observed.Conclusion: based on the investigation results, complaint was confirmed to be an user error.H3 other text : see h10.
Event or Problem Description
It was reported that while using the bd trucount¿ tubes that there was erroneous results.The following information was provided by the initial reporter: according to the customer's report, subpopulations are seen in addition to the bead body population when measuring beads.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16663474
• Report Number: 2916837-2023-00085
• Device Sequence Number: 5924760
• Product Code: GKZ
• UDI-Device Identifier: 00382903403349
• UDI-Public: 00382903403349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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: 02/29/2024
• Device Model Number: 340334
• Device Catalogue Number: 340334
• Device Lot Number: 2237014
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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