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	02/06/2024
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 during use with the bd multitest¿ 58 occurrences of erroneous results were observed.There was no report of patient information or impact.The following information was provided by the initial reporter: mdr safety checklist: patient samples (case).1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no.Ind is experiencing an intermittent issue with an issue with our tbnk runs (as seen below; apologies for the scan quality).We are seeing what looks to be autofluorescent populations in the cd4/cd8 double positive and cd19/cd16+cd56 triple positive gates.As mentioned earlier in the email, this is an intermittent issue seen in both the qc and samples.It is across several instruments and spas as well as seen in manual and spa preparations of the samples.We have completed a quick test to see if a new lot on-site doesn¿t present with this issue.It appears that the current lot of reagent may contain debris (deep red population below on fcse plots) or causing increased debris leading to these abnormal populations.
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 during use with the bd multitest¿ 58 occurrences of erroneous results were observed.There was no report of patient information or impact.The following information was provided by the initial reporter: mdr safety checklist - patient samples (case) 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no.Ind is experiencing an intermittent issue with an issue with our tbnk runs (as seen below; apologies for the scan quality).We are seeing what looks to be autofluorescent populations in the cd4/cd8 double positive and cd19/cd16+cd56 triple positive gates.As mentioned earlier in the email, this is an intermittent issue seen in both the qc and samples.It is across several instruments and spas as well as seen in manual and spa preparations of the samples.We have completed a quick test to see if a new lot on-site doesn¿t present with this issue.It appears that the current lot of reagent may contain debris (deep red population below on fcse plots) or causing increased debris leading to these abnormal populations.

• 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: 18868341
• Report Number: 2916837-2024-00019
• Device Sequence Number: 14214992
• Product Code: GKZ
• UDI-Device Identifier: 00382906629678
• UDI-Public: 00382906629678
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 08/31/2024
• Device Catalogue Number: 662967
• Device Lot Number: 26797
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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