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

Model Number	340486
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	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Medical device expiration date: na.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 that while using bd calibrite 3 beads erroneous results were reported.There was no report of patient impact.The following information was provided by the initial reporter: detail of the problem: after a complaint from the user due to a malfunction of the equipment, a bd engineer identified the following problem: ¨ these batches create faulty settings that generate problems when passing samples (many more events than usual are required and populations fall outside of the gates preset in multiset).
Additional Manufacturer Narrative
H.6.Investigation: a review of the manufacturing records was completed for the reagent and the failure of batches create faulty settings that cause problems when passing samples.Calibrite 3-color bead kit (340486-9277450) batch record was reviewed.The calibrite bead batches # 9086999, 9218184, 9277450 have the same components.Batch record showed that calibrite 3-color bead kits passed their respective specifications prior to submitting to inventory.The retain batch 340486-9218184 was tested and passed the facscomp setup.Root cause could not be determined.The retain sample passed all separations.
Event or Problem Description
It was reported that while using bd calibrite¿ 3 beads erroneous results were reported.There was no report of patient impact.The following information was provided by the initial reporter: detail of the problem: after a complaint from the user due to a malfunction of the equipment, a bd engineer identified the following problem: ¨ these batches create faulty settings that generate problems when passing samples (many more events than usual are required and populations fall outside of the gates preset in multiset).

• 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: 11165540
• Report Number: 2916837-2021-00018
• Device Sequence Number: 19734623
• Product Code: GKZ
• UDI-Device Identifier: 00382903404865
• UDI-Public: 00382903404865
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K961623
• 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): 02/18/2021

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: 9277450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1