MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD TRUCOUNT TUBES; COUNTER, DIFFERENTIAL CELL

Model 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	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k090967, k980858, k971205, k971110, k970326, k970742, and k071143.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that while testing patient samples with bd trucount¿ tubes there were differing results when using 2 different instruments.This occurred on 2 occasions, however, there was no specific impact to patient reported.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer systematically observe a 20% bias of absolute number of cells calculated using trucount tubes on facslyric cytometer or using sysmex cytometer.This is not dependent on the trucount lot.The same tube is analysed approximately at the same time on the 2 instruments.I have checked myself that is was not due to a bad gating positioning.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3008352382-2021-00180 was sent in error.The testing performed was not on patient samples, therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while testing patient samples with bd trucount¿ tubes there were differing results when using 2 different instruments.This occurred on 2 occasions, however, there was no specific impact to patient reported.The following information was provided by the initial reporter, translated from french to english: the customer systematically observe a 20% bias of absolute number of cells calculated using trucount tubes on facslyric cytometer or using sysmex cytometer.This is not dependent on the trucount lot.The same tube is analysed approximately at the same time on the 2 instruments.I have checked myself that is was not due to a bad gating positioning.

• 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
• MDR Report Key: 12174785
• Report Number: 3008352382-2021-00180
• Device Sequence Number: 887579
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Model Number: 340334
• Device Catalogue Number: 340334
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1