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

Model Number 340486

Device Problem Low Readings (2460)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11259331
• MDR Text Key: 253227162
• Report Number: 2916837-2021-00040
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903404865
• UDI-Public: 00382903404865
• Combination Product (y/n): N
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1