MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. 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	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 after using bd trucount¿ absolute counting tubes erroneous results were aquired.No reported patient impact.The following information was provided by the initial reporter: the customer observe surrestimation of absolute counting on its bd facslyric on facsuite clinical software as compared with numeration on its sysmex hematocytometer.
Additional Manufacturer Narrative
H.6: based on the investigation results, the reported surrestimation (overestimation) of absolute count was confirmed to be a usage error.Investigation results that were performed on the indicated failure mode were the following: bhr review and later material usage data as a reference batch showing acceptable performance.Potential cause for customer reported complaint was determined to be the use of a non-bd instrument with a bd reagent, this is a not supported application as per bd trucounttm tubes ifu (part no.23-3483(16); "intended use" section).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 after using bd trucount¿ absolute counting tubes erroneous results were aquired.No reported patient impact.The following information was provided by the initial reporter: the customer observe surrestimation of absolute counting on its bd facslyric on facsuite clinical software as compared with numeration on its sysmex hematocytometer.

• Brand Name: BD TRUCOUNT¿ ABSOLUTE COUNTING 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: 18871226
• Report Number: 2647876-2024-00045
• Device Sequence Number: 7786126
• Product Code: GKZ
• UDI-Device Identifier: 00382906630285
• UDI-Public: (01)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): 07/30/2024

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: 05/31/2025
• Device Catalogue Number: 663028
• Device Lot Number: 3216534
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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