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

Model Number	647205
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2916837-2023-00141
• Device Sequence Number: 6893757
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K131301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown