MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number	337146
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	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd facs¿ lyse wash assistant erroneous results occurred.The following information was provided by the initial reporter: "the problem is cd45 events that are seen after preparation in lwa but not during manual prep.We have debugged with various sample materials, for peripheral blood the problem is not so visible, on the other hand for bone marrow and e.G.Bronchoalveolar lavage" 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes 2.Was there any delay of treatment due to the issue? (go to question #3): unknown 3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): not applicable 4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): unknown 5.Provide details - how and to what extent? (go to question #6): further details on patient impact have been requested to customer.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected information.Date received by manufacturer was changed from 11/15/2023 to 10/12/2023.
Event or Problem Description
It was reported that while using bd facs¿ lyse wash assistant erroneous results occurred.The following information was provided by the initial reporter: "the problem is cd45 events that are seen after preparation in lwa but not during manual prep.We have debugged with various sample materials, for peripheral blood the problem is not so visible, on the other hand for bone marrow and e.G.Bronchoalveolar lavage" 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there any delay of treatment due to the issue? (go to question #3): unknown.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): not applicable.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): unknown.5.Provide details - how and to what extent? (go to question #6): further details on patient impact have been requested to customer.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office contact - (b)(6).G.1 - manufacturing site contact - (b)(6).G.1 - reporting office- becton dickinson and company bd biosciences.H.6 - imdrf annex f code- f26.H6.Investigation summary: based on the investigation results, the reported issue for unexpected populations was not confirmed.Investigation results that were performed on the indicated failure mode were the following: the dhr was reviewed to ensure that the instrument met manufacturing specifications prior to release.An application specialists tried to identify the cause and could not replicate the issue nor determine the problem as the instrument was performing as expected.Although the instrument was used for diagnostic testing, the issue was resolved before the patient sample results were used for any diagnosis or treatment.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that while using bd facs¿ lyse wash assistant erroneous results occurred.The following information was provided by the initial reporter: "the problem is cd45 events that are seen after preparation in lwa but not during manual prep.We have debugged with various sample materials, for peripheral blood the problem is not so visible, on the other hand for bone marrow and e.G.Bronchoalveolar lavage".1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there any delay of treatment due to the issue? (go to question #3): unknown.3.If patient samples were redrawn, was there any change or delay of treatment? (go to question #4): not applicable.4.Was there any physical harm/injury to the patient due to the issue? (if yes or unknown, go to question #5.If no, no further questions required): unknown.5.Provide details - how and to what extent? (go to question #6): further details on patient impact have been requested to customer.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Common Device Name: STATION, PIPETTING DILUTING CLINICAL USE
• 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 18223557
• Report Number: 2916837-2023-00222
• Device Sequence Number: 17560631
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2024

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 Catalogue Number: 337146
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 03/30/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/25/2024; 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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