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

Catalog 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	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: oye common device name: flow cytometric reagents and accessories additional pma / 510(k)#: k170974 , k950057 , k970326 , k970742 , k970836, k971110 , k971205 , k980858 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 during use with bd trucount¿ absolute counting tubes erroneous results were obtained and reported to clinician.There was no patient impact.The following information was provided by the initial reporter, translated from french to english: differences appeared in absolute values between two cyclometers on the same sample id the customer said she is obliged to initiate an official complaint to health authorities.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: h.6 imdrf annex b: b21, h.6 imdrf annex c: c21, h.6 imdrf annex d: d16.
Event or Problem Description
It was reported that during use with bd trucount¿ absolute counting tubes erroneous results were obtained and reported to clinician.There was no patient impact.The following information was provided by the initial reporter, translated from french to english: differences appeared in absolute values between two cyclometers on the same sample id the customer said she is obliged to initiate an official complaint to health authorities.
Event or Problem Description
It was reported that during use with bd trucount¿ absolute counting tubes erroneous results were obtained and reported to clinician.There was no patient impact.The following information was provided by the initial reporter, translated from french to english: differences appeared in absolute values between two cyclometers on the same sample id the customer said she is obliged to initiate an official complaint to health authorities.
Additional Manufacturer Narrative
H.6: based on the investigation results, the reported defect was confirmed, however was not replicated after retain sample testing.Investigation results that were performed on the indicated failure mode were the following: -batch history record (bhr) review a showing acceptable performance.-retain sample testing showing acceptable performance.-review of customer provided information.-potential cause for customer reported complaint was not determined.- for resolution the customer was referred to scientific support.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¿ 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: 19351988
• Report Number: 2916837-2024-00031
• Device Sequence Number: 12540014
• Product Code: GKZ
• UDI-Device Identifier: 00382903403349
• UDI-Public: (01)00382903403349
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 01/30/2025

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 Catalogue Number: 340334
• Device Lot Number: UNKNOWN
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 04/25/2024; 01/30/2025
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 08/28/2024; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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