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	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone#: (b)(6).Initial reporter address: (b)(6).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 there were erroneous results on patient samples with bd calibrite" 3 beads.There was no delay in treatment and no patient impact.The following information was provided by the initial reporter: could you please provide the beads material # reagent used.340486, calibrite 3 color beads kit 25 tests ivd, batch: 0097191.340487, calibrite apc beads 25 tests ivd, batch: 830480.340487, calibrite apc beads 25 tests ivd, batch: 92679.(b)(6): (b)(6) 2020 at 11:13:58 (gmt).In a new telephone contact to monitor the case, he was informed by the laboratory that the problems were not repeated, the routine remains normal.(b)(6): (b)(6) 2020 at 17:09:58 (gmt).The client was asked for new files to continue the investigation.(b)(6): (b)(6) 2020.342975, facscalibur cytometer 4 color basic ivd: serial number: (b)(4).(b)(6): (b)(6) 2020 at 18:57:50 (gmt).Customer reports that compensation made with calibrite (340486 - calibrite 3 color beads kit 25 tests ivd, batch: 0097191 is not passing when using the apc reagent (340487 - calibrite apc beads 25 tests ivd, batch: 830480).The same calibrite, combined with another apc batch ( 340487 - calibrite apc beads 25 tests ivd, batch: 92679) it pass.Failure in fl3 separation, no manual gate adjustment was made.Calibrite lot#: 0097191 that is not passing is already close to the expiration date (11/30/20).Files were requested to attach to the case, and proceed with the investigation.(b)(6): (b)(6) 2020 at 18:46:20 (gmt).Reality customer.
Event or Problem Description
It was reported that there were erroneous results on patient samples with bd calibrite¿ 3 beads.There was no delay in treatment and no patient impact.The following information was provided by the initial reporter: could you please provide the beads material # ? reagent used; 340486 - calibrite 3 color beads kit 25 tests ivd , batch: 0097191, 340487 - calibrite apc beads 25 tests ivd, batch: 830480, 340487 - calibrite apc beads 25 tests ivd, batch: 92679.Edione reis : 2020-12-09 11:13:58 (gmt): in a new telephone contact to monitor the case, he was informed by the laboratory that the problems were not repeated, the routine remains normal.Edione reis : 2020-12-08 17:09:58 (gmt): the client was asked for new files to continue the investigation.Rosmary penafiel,dec 03,2020: facscomp report attached.342975 - facscalibur cytometer 4 color basic ivd - serial number: (b)(6).Edione reis : 2020-11-25 18:57:50 (gmt): customer reports that compensation made with calibrite (340486 - calibrite 3 color beads kit 25 tests ivd , batch: 0097191 ) is not passing when using the apc reagent (340487 - calibrite apc beads 25 tests ivd, batch: 830480).The same calibrite, combined with another apc batch ( 340487 - calibrite apc beads 25 tests ivd, batch: 92679) it pass.Failure in fl3 separation, no manual gate adjustment was made.Calibrite lot 0097191 that is not passing is already close to the expiration date (11/30/2020).Files were requested to attach to the case and proceed with the investigation.Edione reis : 2020-11-25 18:46:20 (gmt); reality customer.
Additional Manufacturer Narrative
After further investigation the mdr2916837-2020-00322 was deemed not reportable and should not have been filed.This complaint is not mdr reportable."this is pre-patient testing to qualify the reagent.If it passes qc even though there is variation, customer can still obtain the correct result.Also, some customers qc specifications window is a lot tighter than our qc window spec.This is quite common.Finally, this could be used on a non-bd instrument such as coulter.".

• 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: 11060477
• Report Number: 2916837-2020-00322
• Device Sequence Number: 14103800
• Product Code: GKZ
• UDI-Device Identifier: 00382903404865
• UDI-Public: 00382903404865
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/19/2021

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: 03/31/2022
• Device Model Number: 340486
• Device Catalogue Number: 340486
• Device Lot Number: 0097191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1