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

Model Number	340912
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the package insert for bd¿ multi-check has incorrect mean value for % total for cd3+cd4+, or the range is incorrect.There was no report of patient impact.The following information was provided by the initial reporter: in the lotspecific assay values and expected ranges package insert one of the values for % total for cd3+cd4+ the mean value of 50,4 % is not correct, should be 51,9% or the range of 43,9-59,9 is not correct.Customer use bd multi-check control cat no #340912 and the bd multi-check cd4 low control, cat no #340915.For the cd4 low control the values are correct.Please check the values for the normal control.
Additional Manufacturer Narrative
H.6.Investigation: ¿ scope.The scope of issue is limited to parts 340911 and 340912 and lot bm0321.¿ manufacturing defect trend: this product is manufactured by a third party.Manufacturing non-conformance data are not routinely available.¿ complaint trend: there are no additional complaints besides this complaint for the date range between 03mar2020 and 03mar2021.¿ batch history record (bhr) review: documentation for part 340911, bm0321n was reviewed.It was found that the materials met manufacturing specifications prior to release.¿ retain sample evaluation / testing: the retain sample part and lot was not tested prior to expiration on 02apr2021 because the user is referring to a labeling issue.¿ returned sample evaluation: the sample was not requested to be returned.This is a labeling issue.¿ investigation result / analysis: the supplier confirmed a discrepancy in the published table of expected assay value ranges.Scar #(b)(4) was opened to address this issue.
Event or Problem Description
It was reported the package insert for bd¿ multi-check has incorrect mean value for % total for cd3+cd4+, or the range is incorrect.There was no report of patient impact.The following information was provided by the initial reporter: in the lotspecific assay values and expected ranges package insert one of the values for % total for cd3+cd4+ the mean value of 50,4 % is not correct, should be 51,9% or the range of 43,9-59,9 is not correct.Customer use bd multi-check control cat no #340912 and the bd multi-check cd4 low control, cat no #340915.For the cd4 low control the values are correct.Please check the values for the normal control.

• Brand Name: BD MULTI-CHECK
• 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: 11595041
• Report Number: 2916837-2021-00122
• Device Sequence Number: 3449533
• Product Code: GKZ
• UDI-Device Identifier: 00382903409129
• UDI-Public: 00382903409129
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961610
• 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): 07/01/2021

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: 04/02/2021
• Device Model Number: 340912
• Device Catalogue Number: 340912
• Device Lot Number: BM0321N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1