MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD BIOSCIENCES FACS; AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO

Model Number 647205

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

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

It was reported that during use with the bd facs¿ sample prep assistant iii there were erroneous results on patient samples.The following information was provided by the initial reporter: the samples that are prepared by the spa ii equipment do not provide readings and are invalidated by the cytometer.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.Was carryover observed on patient samples? no.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that during use with the bd facs¿ sample prep assistant iii there were erroneous results on patient samples.The following information was provided by the initial reporter: correction from the wfi- checklist: are there erroneous results on patient samples for diagnostic test? no.The samples that are prepared by the spa ii equipment do not provide readings and are invalidated by the cytometer.¿ 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.Was carryover observed on patient samples? no.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2023-00141 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

• Brand Name: FACS
• Type of Device: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17343458
• MDR Text Key: 319220052
• Report Number: 2916837-2023-00141
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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