MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD LEUCOCOUNT; COUNTER, DIFFERENTIAL CELL

Model Number	341003
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	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g.5.Pma / 510(k)#: bk000036.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 while testing with bd leucocount¿ low results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: low results obtained with rbc high compared to expected values.Noticed after use.Results obtained with rbch controls were lower than expected.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00239 was sent in error.The complaint is on qc control leucocount rbd samples and therefore, is not considered to be a reportable malfunction.
Event or Problem Description
It was reported while testing with bd leucocount¿ low results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: low results obtained with rbc high compared to expected values.Noticed after use.Results obtained with rbch controls were lower than expected.

• Brand Name: BD LEUCOCOUNT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11834657
• Report Number: 2916837-2021-00239
• Device Sequence Number: 16937110
• Product Code: GKZ
• UDI-Device Identifier: 00382903410033
• UDI-Public: 00382903410033
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: BK000035
• 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): 06/14/2021

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: 341003
• Device Catalogue Number: 341003
• Device Lot Number: LR0321H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1