MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. 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	10/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd trucount¿ absolute counting tubes an over estimation of absolute counts was experienced.There was no report of patient impact.The following information was provided by the initial reporter."problem encountered with patient samples: excessive deviation of the absolute value of lymphocytes calculated with trucount tubes compared with cbc lymphocytes, compared with the deviation values defined by the laboratory.".
Additional Manufacturer Narrative
H3.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd trucount¿ absolute counting tubes an over estimation of absolute counts was experienced.There was no report of patient impact.The following information was provided by the initial reporter."problem encountered with patient samples: excessive deviation of the absolute value of lymphocytes calculated with trucount tubes compared with cbc lymphocytes, compared with the deviation values defined by the laboratory.".
Additional Manufacturer Narrative
The following fields have been updated: unique identifier number: (b)(4) labeled for single use- no.H6.Investigation summary: based on the investigation results, the reported issue stating that wrong absolute numbers of cells were observed using a specific lot of trucount absolute counting tubes was confirmed based on the data provided by the customer.Investigation results that were performed on the indicated failure mode were the following: the retain testing was performed and the results showed that the product bead count was within release specification.Batch history record review for part 663028 batch 4281608 and subassembly component showed that the product met all the manufacturing specifications prior to release.Potential cause was not determined, a replacement lot was provided to the customer 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.

• Brand Name: BD TRUCOUNT¿ TUBES
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• 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: 20993611
• Report Number: 2647876-2024-00173
• Device Sequence Number: 12795921
• Product Code: GKZ
• UDI-Device Identifier: 00382906630285
• UDI-Public: (01)00382906630285(10)4281608(11)241007(17)260831
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2025

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: 08/31/2026
• Device Catalogue Number: 663028
• Device Lot Number: 4281608
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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