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

Catalog 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	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10 - g.5.Additional pma / 510(k)#: k980858, k971205, k971110, k970326, k970742, k071143.E.1.Initial reporter facility name: (b)(6).H.3.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¿ absolute counting tubes was unable to display all known trucount beads during ivd testing.The following information was provided by the initial reporter: "for half of samples insufficient bead number was acquired for the trucount beads lot 22103.This was observed on facscantoii and facscalibur instruments.No problem detected once another bead lot was used.".
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office contact - fahmy razak mdr.G.1 - manufacturing site contact - fahmy razak mdr.H.6: investigation summary: based on the investigation results, the reported issue of half of the samples having insufficient bead number, was confirmed.Investigation results that were performed on the indicated failure mode were the following: the batch history record (bhr) was reviewed and the product met all the manufacturing specifications prior to release including bead count test parameters.Retain sample analysis was evaluated and results for the bead count were acceptable, meeting standard deviation and %cv criteria.The potential cause was not determined, and the issue was resolved once another bead lot was used.Conditions that might produce the reported defect are broken pellets, inadequate storage of tubes, and prolonged exposure of tubes to the environment.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd trucount¿ absolute counting tubes was unable to display all known trucount beads during ivd testing.The following information was provided by the initial reporter: "for half of samples insufficient bead number was acquired for the trucount beads lot 22103.This was observed on facscantoii and facscalibur instruments.No problem detected once another bead lot was used.".

• Brand Name: BD TRUCOUNT¿ ABSOLUTE COUNTING 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18242935
• Report Number: 2916837-2023-00223
• Device Sequence Number: 6644809
• Product Code: GKZ
• UDI-Device Identifier: 00382906630285
• UDI-Public: (01)00382906630285
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K090967
• 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): 03/25/2024

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: 05/31/2024
• Device Catalogue Number: 663028
• Device Lot Number: 22103
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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