MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD TRUCOUNT¿ 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	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that erroneous results were observed on patient samples during use with the bd trucount¿ tubes.The following information was provided by the initial reporter: 1.If there was any contamination that involves patient sample? no.2.Were erroneous results observed on patient samples? yes.3.Whether carryover happened on patient samples? no.Leucocyte counts with lot 3186043 are too high and deviate from hemato analyzer with 25% when did the incident occur? during use detailed incident description leucocyte counts with lot 3186043 are higher compared to counts from same sample with hemato analyzer.Deviation with 25% for both patient samples and control material.With multiple preparations, by multiple technicians.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: reporting office: becton dickinson and company bd biosciences.Reporting office contact: fahmy razak - mdr.Manufacturing site contact: fahmy razak - mdr.H.6: based on the investigation results, the reported issue, trucount tubes lot 23128, that produced leucocyte counts too high compared to counts from same sample using a hemato analyzer (25% deviation) resulting in erroneous results was not confirmed as product is performing as intended.Investigation results that were performed on the indicated failure mode were the following: retain sample testing that showed that the product was performing as intended.Batch history record (bhr) review showing that the product was manufactured in compliance with established processes and procedures.The potential cause of the variability in the results observed by the customer using different technologies is not determined.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 erroneous results were observed on patient samples during use with the bd trucount¿ tubes.The following information was provided by the initial reporter: 1.If there was any contamination that involves patient sample? no.2.Were erroneous results observed on patient samples? yes.3.Whether carryover happened on patient samples? no.Leucocyte counts with lot 3186043 are too high and deviate from hemato analyzer with 25% when did the incident occur? during use.Detailed incident description.Leucocyte counts with lot 3186043 are higher compared to counts from same sample with hemato analyzer.Deviation with 25% for both patient samples and control material.With multiple preparations, by multiple technicians.

• 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 CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17839452
• Report Number: 2647876-2023-00206
• Device Sequence Number: 7418285
• 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: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: 04/30/2025
• Device Catalogue Number: 663028
• Device Lot Number: 3186043
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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