MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVD; MIXTURE, HEMATOLOGY QUALITY CONTROL

Model Number	349703
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that during use with a bd multi-check cd4 low ctrl 1x2.5ml us-ivd results show extra population in low control.There was no impact to patient.The following information was provided by the initial reporter: customer reporting extra population present in low control only.Normal control looks as expected.Requires a gate adjustment to correct for this.Customer has followed up they ordered 2 vials of catalog 349703 lot 1020 that show this extra population.They have confirmed this did not affect patient data as they noticed the population and were able to gate them out.Quality is aware of this issue and is investigating.Additionally, on 2020-10-07 the fse provided the following additional information: customer has followed up they ordered 2 vials of catalog 349703 lot 1020 that show this extra population.They have confirmed this did not affect patient data as they noticed the population and were able to gate them out.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 2916837-2020-00206 was sent in error.Error was with control not patient samples for clinical use, therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that during use with a bd multi-check cd4 low ctrl 1x2.5ml us-ivd results show extra population in low control.There was no impact to patient.The following information was provided by the initial reporter: customer reporting extra population present in low control only.Normal control looks as expected.Requires a gate adjustment to correct for this.Customer has followed up they ordered 2 vials of catalog 349703 lot 1020 that show this extra population.They have confirmed this did not affect patient data as they noticed the population and were able to gate them out.Quality is aware of this issue and is investigating.Additionally, on 2020-10-07 the fse provided the following additional information: customer has followed up they ordered 2 vials of catalog 349703 lot 1020 that show this extra population.They have confirmed this did not affect patient data as they noticed the population and were able to gate them out.

• Brand Name: BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVD
• Common Device Name: MIXTURE, HEMATOLOGY QUALITY CONTROL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10726257
• Report Number: 2916837-2020-00206
• Device Sequence Number: 2908892
• Product Code: JPK
• UDI-Device Identifier: 00382903497034
• UDI-Public: 00382903497034
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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 Model Number: 349703
• Device Catalogue Number: 349703
• Device Lot Number: BM1020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2020
• Supplement Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1