MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II FLOW CYTOMETER; COUNTER, DIFFERENTIAL CELL

Catalog Number 338960

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that during use with a bd facscanto¿ ii flow cytometer the control counts of progenitor cells were out of upper limit.There was no reported patient impact.The following information was provided by the initial reporter, translated from spanish to english: control counts of progenitor cells out of upper limit.Patient samples for clinical use.If they were patient samples for clinical use, was there any impact to the patient? no results were released and no patient was treated.Were samples redrawn? yes.Was there any delay in treatment? no.Control counts of progenitor cells out of upper limit.There was not a new collection from patients.The samples were prepared and analyzed again in the instrument.

Event Description

It was reported that during use with a bd facscanto¿ ii flow cytometer the control counts of progenitor cells were out of upper limit.There was no reported patient impact.The following information was provided by the initial reporter, translated from spanish to english: control counts of progenitor cells out of upper limit.Patient samples for clinical use.If they were patient samples for clinical use, was there any impact to the patient? no results were released and no patient was treated.Were samples redrawn? yes.Was there any delay in treatment? no.Control counts of progenitor cells out of upper limit.There was not a new collection from patients.The samples were prepared and analyzed again in the instrument.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 2916837-2020-00180 was sent in error.The erroneous result that occurred was not on a patient sample it was a control sample and therefore, not considered to be a reportable malfunction.

• Brand Name: BD FACSCANTO II FLOW CYTOMETER
• 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: 10662622
• MDR Text Key: 233335083
• Report Number: 2916837-2020-00180
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 0382903389605
• Combination Product (y/n): N
• PMA/PMN Number: K062087
• 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: 01/28/2021

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
• Device Operator: Other
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other