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

Model Number	337166
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	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 testing patient samples with bd multitest¿ there was an absence of lymphocytes events.Samples were re-prepared with new vial of sample lot with optimal staining patterns.Results were not reported and there was no impact to patient.The following information was provided by the initial reporter: samples acquired with canto sw (tbnk+truc ) showed absence of lymphocytes events.Only trucount were visible and well positioned on the plot.Samples were re-prepared but showed always the same pattern.A new vials of the same lot were used to re-prepare the same sample and showed an optimal staining pattern.No result were sent to patient.All samples are going to be prepared with the good new vial of the same lot.Probably a signal degradation occurred for unknown reasons in the old vial after vial opening.Was the event caused by a use error? no it wasn't.It is not use error, the reagent is damaged.Did the patient/medical provider perceive results to be correct and report them? no.If applicable, is there a confirmatory test standard procedure? they just repeated the test with a different reagent coming from a different vial, and results were visible on the screen.Was a patient treated based on erroneous results? no.Was there any adverse impact to the patient due to the treatment? no.Was there any delay in diagnosis or treatment due to this event and if yes, how much? no.
Event or Problem Description
It was reported that while testing patient samples with bd multitest¿ there was an absence of lymphocytes events.Samples were re-prepared with new vial of sample lot with optimal staining patterns.Results were not reported and there was no impact to patient.The following information was provided by the initial reporter: samples acquired with canto sw (tbnk+truc ) showed absence of lymphocytes events.Only trucount were visible and well positioned on the plot.Samples were re-prepared but showed always the same pattern.A new vials of the same lot were used to re-prepare the same sample and showed an optimal staining pattern.No result were sent to patient.All samples are going to be prepared with the good new vial of the same lot.Probably a signal degradation occurred for unknown reasons in the old vial after vial opening.Was the event caused by a use error? no it wasn't.It is not use error, the reagent is damaged.Did the patient/medical provider perceive results to be correct and report them? no.If applicable, is there a confirmatory test standard procedure? they just repeated the test with a different reagent coming from a different vial, and results were visible on the screen.Was a patient treated based on erroneous results? no.Was there any adverse impact to the patient due to the treatment? no.Was there any delay in diagnosis or treatment due to this event and if yes, how much? no.
Additional Manufacturer Narrative
H.6.Investigation: scope of issue: the scope of the issues is limited to 337166-30559, 6 color tbnk with trucount reagent.Problem statement: samples acquired in canto showed absence of lymphocytes events and trucount beads were present.A new vial of the same lot was tested and showed acceptable staining performance.Manufacturing defect trend: there are 0 qn¿s related to the reported issue.Date range 06/11/2020 to 06/11/2021.Root cause analysis: based on the investigation result the root cause was not determined.Complaint history review: there are 3 reported performance complaints including this complaint and 2 others.Date range from 6/11/2020 to 6/11/2021.Risk review: bd multitest and tritest device family, ivd devices risk analysis, rev 06 sap doc# (b)(4) was reviewed.Hazard #: 3.1.4.Hazard: functional.Hazard cause: unstable device-degrades before assigned expiration date.Harmful effects: wrong result (potential patient harm) -not matching profile.Severity: 3.Probability: 2.Risk index: 6.Risk control: stability studies will be executed to confirm the stability of the device.Control material would indicate there is a problem.Implementation: stability study protocols.Effectiveness: stability study reports.Hazard #: 3.1.12.Hazard: functional.Hazard cause: the device is unable to accurately identify the markers of interest.Harmful effects: wrong result (potential patient harm).Severity: 3.Probability: 5.Risk index: 15.Risk control: the design of the device will include antibodies specific for the markers of interest, and requirements for accuracy will need to be met.The manufacturing process has been validated, and appropriate qc testing in place to confirm device performance for each batch of reagents.Implementation: development report for antibody clones used in the reagent.Accuracy protocol (sap# (b)(4).Process validation which includes pfmea.Reagent 60-stage and 91-stage qc testing.Effectiveness: development report for antibody clones used in the reagent.Accuracy report (sap# (b)(4).Process validation which includes mitigated pfmea (337166-01fmea).Batch records showing passing qc testing results.New hazard: none.Mitigation(s) sufficient yes.If no (to above), what actions will be taken? a risk analysis is not required if this is not a safety or reportable event.Batch history record (bhr) review: the following batch records were reviewed.337166-30559.91-0717-0315504.The materials met all the manufacturing specification prior to release.Returned sample analysis: no sample was returned from the customer and no photo was attached in the complaint.Investigation of the complaint were conducted by testing the retain sample to stain normal peripheral blood specimen.Retain sample analysis: lyse no wash staining method was used to stain normal peripheral blood specimens with retain reagent samples: (1) #91-0717-315504, lot mentioned in the complaint and (2) #91-91-0717-0289097, lot used as reference for comparison.Stained sample was acquired in lyric instrument using lnw assay.Analysis of the data showed the presence of lymphocyte population stained with cd45 percp-cy5.5, which is one of the components of tbnk reagent.All the other population of interest on the stained samples were also detected by the markers of the tbnk reagents.These populations can be gated separately as shown in dot plots.Both reagent samples showed similar performance.Conclusion: based on the investigation result: the customer observation was unconfirmed.Investigation conclusion: based on the investigation result, complaint was unconfirmed.

• 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
• MDR Report Key: 12084383
• Report Number: 2916837-2021-00292
• Device Sequence Number: 17233112
• Product Code: GKZ
• UDI-Device Identifier: 00382903371662
• UDI-Public: 00382903371662
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060375
• 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): 07/21/2021

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 Expiration Date: 01/31/2022
• Device Model Number: 337166
• Device Catalogue Number: 337166
• Device Lot Number: 30559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1