MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD CALIBRITE 3 BEADS; COUNTER, DIFFERENTIAL CELL

Model Number	340486
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2021
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.(b)(4).
Event or Problem Description
It was reported while testing with bd calibrite¿ 3 beads there was a poor fl3 performance.Confirmatory testing performed running test simultaneously on to rule out machine issue.New lot of beads passed.The following information was provided by the initial reporter: nature of incident: poor fl3 performance.The affected calibrite bead lot number is 0002577 tested same calibrite bead on 2 unit facscalibur simultaneously (machine a & machine b) to rule out machine problem.Run facscomp using different lot of calibrite bead #0212458 and it show pass.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2021-00040 was sent in error.There were no patient samples involved, and reagent lot-to-lot variation is not considered to be a reportable malfunction.
Event or Problem Description
It was reported while testing with bd calibrite¿ 3 beads there was a poor fl3 performance.Confirmatory testing performed running test simultaneously on to rule out machine issue.New lot of beads passed.The following information was provided by the initial reporter: nature of incident: poor fl3 performance.The affected calibrite bead lot number is 0002577.Tested same calibrite bead on 2 unit facscalibur simultaneously (machine a & machine b) to rule out machine problem.Run facscomp using different lot of calibrite bead #0212458 and it show pass.

• Brand Name: BD CALIBRITE 3 BEADS
• 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: 11259331
• Report Number: 2916837-2021-00040
• Device Sequence Number: 715465
• Product Code: GKZ
• UDI-Device Identifier: 00382903404865
• UDI-Public: 00382903404865
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K973483
• Number of Events Summarized: 1
• Summary Report (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): 02/16/2021

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: 02/28/2021
• Device Model Number: 340486
• Device Catalogue Number: 340486
• Device Lot Number: 0002577
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1