MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. 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	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.E.1.Initial reporter facility name: (b)(6) hospital.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 while using bd multitest¿ erroneous results were observed.There was no report of user impact.The following information was provided by the initial reporter: the customer found that as long as this lot (34028) 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: 34028.This will cause incorrect result for both cd4+ and cd8+% and cell counts.
Additional Manufacturer Narrative
H.6: based on the investigation results, the reported performance issue defect of background signal against product 662967 (bd multitest 6-color tbnk reagent, ivd) lot 34028 was confirmed but reported defect was not reproduced and this product lot performed as intended.Investigation results that were performed on the indicated failure mode were the following: retain sample testing by flow cytometry, subassembly material bhr review including flow cytometry data obtained during release testing against reference batch.Based on investigation results, a potential cause was not determined.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 while using bd multitest¿ erroneous results were observed.There was no report of user impact.The following information was provided by the initial reporter: the customer found that as long as this lot(34028) 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 34028.This will cause incorrect result for both cd4+ and cd8+% and cell counts.
Additional Manufacturer Narrative
The following field has been updated with corrected information: d.4.Unique identifier (udi) #: (b)(4).H.6 imdrf annex b: b21.H.6 imdrf annex c: c21.H.6 imdrf annex d: d16.
Event or Problem Description
It was reported that while using bd multitest¿ erroneous results were observed.There was no report of user impact.The following information was provided by the initial reporter: the customer found that as long as this lot(34028) 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 34028.This will cause incorrect result for both cd4+ and cd8+% and cell counts.

• Brand Name: BD MULTITEST¿
• 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: 18914887
• Report Number: 3008352382-2024-00002
• Device Sequence Number: 12452624
• Product Code: GKZ
• UDI-Device Identifier: 00382906629678
• UDI-Public: (01)00382906629678(11)231130(17)241231(10)34028
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2024

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: 12/31/2024
• Device Catalogue Number: 662967
• Device Lot Number: 34028
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024; 08/29/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 08/28/2024; 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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