MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSPRESTO INSTRUMENT; SEE H.10

Catalog Number 651000

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated multicolor fluorescent imaging cytometric analysis system.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.

Event Description

It was reported that there were erroneous results while using bd facspresto instrument.These are related to ivd instrument hardware, ivd/asr reagent, and ruo ldt reagent.It is unclear whether the erroneous results were caused from an ruo reagent, or a combination of ivd or ruo reagents, or the instrument.The following information was provided by the initial reporter: in "(b)(4)", it has been mentioned as "poor sample dispersion in cartridge".As a part of compliance review, could you please answer the following questions? are there erroneous results on patient samples for diagnostic test? yes.Was there any delay of treatment due to the issue? no.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.Provide details - how and to what extent? no.What is the current medical status? no.

Manufacturer Narrative

After further review of additional information mfr#2916837-2021-00420 has been determined to be not reportable.The instrument was unable to detect the cartridge.This particular event is likely to be associated with a short-term interruption in the devices ability to perform as intended, a clinically inconsequential prolongation in diagnostic identification.This would require the user to acquire another component to be used in order to use instrument as intended.This is unlikely to cause serious injury.As a result mfr#2916837-2021-00420 is null and void.

Event Description

It was reported that there were erroneous results while using bd facspresto instrument.These are related to ivd instrument hardware, ivd/asr reagent, and ruo ldt reagent.It is unclear whether the erroneous results were caused from an ruo reagent, or a combination of ivd or ruo reagents, or the instrument.The following information was provided by the initial reporter: in " (b)(4) ", it has been mentioned as " poor sample dispersion in cartridge" as a part of compliance review, could you please answer the following questions? are there erroneous results on patient samples for diagnostic test? yes.Was there any delay of treatment due to the issue? no.If patient samples were redrawn, was there any change or delay of treatment? no.Was there any physical harm/injury to the patient due to the issue? no.Provide details - how and to what extent? no.What is the current medical status? no.

• Brand Name: BD FACSPRESTO INSTRUMENT
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12708271
• MDR Text Key: 283253665
• Report Number: 2916837-2021-00420
• Device Sequence Number: 1
• Product Code: PMG
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: K150815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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: 651000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1