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

Model Number	644611
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	06/07/2023
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 while using the bd multitest¿ that there was contamination.The following information was provided by the initial reporter: the customer found that as long as this batch of lot is stained, in the apc vs ssc and cd4 vs cd8 graphs, there is noise, but other lots are normal without noise.
Event or Problem Description
It was reported that while using the bd multitest¿ that there was contamination.The following information was provided by the initial reporter: the customer found that as long as this batch of lot is stained, in the apc vs ssc and cd4 vs cd8 graphs, there is noise, but other lots are normal without noise.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.Customer responded that there was no contamination on patient samples, therefore, this is not considered to be a reportable malfunction.

• Brand Name: BD MULTITEST¿
• 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: phillip emmert ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17262380
• Report Number: 2916837-2023-00134
• Device Sequence Number: 6698064
• Product Code: GKZ
• UDI-Device Identifier: 00382906446114
• UDI-Public: 00382906446114
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 07/06/2023

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: 02/29/2024
• Device Model Number: 644611
• Device Catalogue Number: 644611
• Device Lot Number: 23480
• 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: 06/11/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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