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

Catalog Number	662967
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	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.5.Pma / 510(k)#: k090967.G.5.Pma / 510(k)#: k170974.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 erroneous results were observed during use with bd multitest ivd reagent.The following information was provided by the initial reporter: the customer found that as long as this batch of lot is stained, in the cd45 vs ssc, cd4 vs cd8 plots, there are huge noise, but other lots are normal without any noise.Very clean cd45 stain unlike lot 69761.
Additional Manufacturer Narrative
H.6 investigation summary: based on the investigation results, the reported issue (non-specific staining creating unusual staining patterns for cd4+cd+8 populations) was confirmed.Investigation results that were performed on the indicated failure mode were the following: data provided by customer was reviewed.Retain testing results showed the presence of a non-specific staining.Potential cause is determined to be manufacturing related.Additional controls have been put in place in the manufacturing stage specific to the supplied component.Corrective action was initiated to address the root cause and preventive actions.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.
Event or Problem Description
It was reported that erroneous results were observed during use with bd multitest ivd reagent.The following information was provided by the initial reporter: the customer found that as long as this batch of lot is stained, in the cd45 vs ssc, cd4 vs cd8 plots, there are huge noise, but other lots are normal without any noise.Very clean cd45 stain unlike lot 69761.

• 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18679416
• Report Number: 2916837-2024-00015
• Device Sequence Number: 20660300
• Product Code: GKZ
• UDI-Device Identifier: 00382906629678
• UDI-Public: 00382906629678
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 662967
• Device Lot Number: 69761
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 94830
• Patient Sequence Number: 1
• Patient Sex: Unknown