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

Model Number	340523
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	04/07/2021
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 while running patient samples with bd leucocount¿ erroneous results obtained when running on facsvia 590153, however, running same samples on facscalibur didn't generate the issue.There was no report of patient impact.The following information was provided by the initial reporter: leucocount human reagent kit 50tst ivd - change in populations in the plots 2850854 340523_1029004 - leucocount human reagent kit 50tst ivd - change in populations in the plots.Customer states she encountered issues with their facsvia 590153 using the leucocount kit on the 7th of april.However, running the exact same sample with the exact same kit lot on their facscalibur didn¿t generate issue.They were able to generate the data properly with the facscalibur.They opened a new kit lot 1029004 on the 22nd of april, for which they did not experience the issue.
Additional Manufacturer Narrative
H.6.Investigation: ¿ problem statement: customer reported seeing the low results (b)(6) 2021.¿ scope the scope of issue is limited to part 340523 and lot 1050800.¿ manufacturing defect trend: there are no manufacturing non-conformances related to this complaint #2850828 for the date range from 04may2020 to 04may2021.¿ complaint trend: there were three other complaints related to the reported issue in addition to this complaint #2850828 for the date range from 04may2020 to 04may2021.¿ batch history record (bhr) review: bhr part lot was reviewed for part 340523, lot 1050800 and is attached.No non-conformances were recorded; the material met all manufacturing specifications prior to release.¿ retain sample evaluation / testing: retained samples of both leucocount reagent lots were retested with two trucount lots.Results of the leucocount retest do not confirm the complaint.¿ returned sample evaluation: the sample was not requested to be returned because the aberrant results reported by the user were not reproducible.Retained samples of both leucocount reagent lots were retested with two trucount lots.This is the only performance complaint reported for part 340523 and lot 1050800 out of 1,539 units produced.¿ investigation result / analysis: this is the only performance complaint reported for part 340523 and lot 1050800 out of 1,539 units produced.Retesting shows normal distributions of cells and beads within the leucocount program; it is possible that the compensation differences between the facsvia and facscanto are responsible for population shifts observed.The investigation was performed and based on the review of complaint trend, defect trend, bhr, root cause and risk analysis, the reported complaint was not confirmed.¿ risk analysis: risk review: leucocount risk management file rmf340523, revision a, was reviewed.Hazard(s) identified? yes if no (to above), what actions will be taken? hazard:_wrong answer_____ cause:_various_____ harmful effects:_leucocytes miscounted_____ severity: __=3____ probability: __=5___ ri: __=iv____ risk control: _various_____ new hazard: _no__ mitigation(s) sufficient yes; the user indicated that patient samples were never at risk.¿ root cause analysis: based on the investigation result, root cause was not determined.¿ investigation conclusion: based on the investigation result, complaint was not confirmed.H3 other text : see h.10.
Event or Problem Description
It was reported while running patient samples with bd leucocount¿ erroneous results obtained when running on facsvia 590153, however, running same samples on facscalibur didn't generate the issue.There was no report of patient impact.The following information was provided by the initial reporter: leucocount human reagent kit 50tst ivd - change in populations in the plots 2850854 340523_1029004 - leucocount human reagent kit 50tst ivd - change in populations in the plots customer states she encountered issues with their facsvia 590153 using the leucocount kit on the (b)(6).However, running the exact same sample with the exact same kit lot on their facscalibur didn't generate issue.They were able to generate the data properly with the facscalibur.They opened a new kit lot 1029004 on the (b)(6), for which they did not experience the issue.

• Brand Name: BD LEUCOCOUNT
• 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: 11904712
• Report Number: 2916837-2021-00260
• Device Sequence Number: 14338293
• Product Code: GKZ
• UDI-Device Identifier: 00382903405237
• UDI-Public: 00382903405237
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BK970046
• 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): 09/30/2021

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: 11/30/2021
• Device Model Number: 340523
• Device Catalogue Number: 340523
• Device Lot Number: 0192021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1