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	10/26/2023
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 while using bd trucount¿ absolute counting tubes erroneous results have occurred.The following information was provided by the initial reporter: abnormal high results with lot 23128.When did the incident occur? during use.Trucount tubes give either normal or higher results, up to +25%.We have verified the trucount abort to eliminate a problem of undercounting of beads by aborts.
Additional Manufacturer Narrative
This correction report is being sent to correct the previously submitted report 2647876-2023-00591 date received by manufacturer is 15-nov-2023.G4: date received by manufacturer: 15-nov-2023.
Event or Problem Description
It was reported that while using bd trucount¿ absolute counting tubes erroneous results have occurred.The following information was provided by the initial reporter: abnormal high results with lot 23128 when did the incident occur? during use trucount tubes give either normal or higher results, up to +25%.We have verified the trucount abort to eliminate a problem of undercounting of beads by aborts.
Event or Problem Description
It was reported that while using bd trucount¿ absolute counting tubes erroneous results have occurred.The following information was provided by the initial reporter: abnormal high results with lot 23128.When did the incident occur? during use.Trucount tubes give either normal or higher results, up to +25%.We have verified the trucount abort to eliminate a problem of undercounting of beads by aborts.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office contact - fahmy razak.G.1 - manufacturing site contact - fahmy razak.H6.Investigation summary:based on the investigation results, the reported issue of trucount absolute counting tubes, lot 23128, producing abnormal high results was confirmed based on the data provided by the customer.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.Bhr review that showed that the product was manufactured in compliance with established process.Potential cause of customer claim was not determined.Product risk analysis identified variability among tubes as a cause for inaccurate results.Bd followed up with the customer and no response was received regarding the resolution.Complaints received for this device will continue to be tracked and trended.Information will be captured on trend reports and monitored to determine if further action is needed.

• 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: 18208860
• Report Number: 2647876-2023-00591
• Device Sequence Number: 6295230
• Product Code: GKZ
• UDI-Device Identifier: 00382903403349
• UDI-Public: 00382903403349
• 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,Followup
• Report Date (Section B): 04/30/2024

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 Catalogue Number: 663028
• Device Lot Number: 23128
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 04/30/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/01/2023; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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