MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD HORIZON¿ HU CD196 (CCR6) PE-CF594 11A9 50TST

Catalog Number 564816

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

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 that there is a dimmer staining on patient samples with a bd horizon¿ hu cd196 (ccr6) pe-cf594 11a9 50tst.The following information was provided by the initial reporter: customer is in a diagnostic laboratory and is testing on patient samples and used lot # 0024814.Customer identified that there is dimmer staining compared to previous batches they have used.Additionally, on 2020-06-16 the bd rep provided the following additional information received from customer: we use this antibody in a clinical assay, and report a subset of tcells (th17) according to expression of ccr6.There has not been any ¿diagnosis¿ based on the results alone.This test is more as an adjunct to clinical data and other laboratory tests.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 3007886372-02020-00001 was sent in error.It has been determined the complaint is for a lot to lot variation which is not considered to be a reportable malfunction.

Event Description

It was reported that there is a dimmer staining on patient samples with a bd horizon¿ hu cd196 (ccr6) pe-cf594 11a9 50tst.The following information was provided by the initial reporter: customer is in a diagnostic laboratory and is testing on patient samples and used lot # 0024814.Customer identified that there is dimmer staining compared to previous batches they have used.Additionally, on (b)(6) 2020 the bd rep provided the following additional information received from customer: we use this antibody in a clinical assay, and report a subset of tcells (th17) according to expression of ccr6.There has not been any ¿diagnosis¿ based on the results alone.This test is more as an adjunct to clinical data and other laboratory tests.

• Brand Name: BD HORIZON¿ HU CD196 (CCR6) PE-CF594 11A9 50TST
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; 10865 road to the cure; suite no. 210; san diego CA 92121
• MDR Report Key: 10159374
• MDR Text Key: 205922606
• Report Number: 3007886372-2020-00001
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 06/17/2020

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
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 564816
• Device Lot Number: 0024814
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other