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	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.E.1.Initial reporter phone#: (b)(6).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 erroneous results were observed on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: 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): no.3.If patient samples were re-drawn, was there any change or delay of treatment? (go to question #4.): no.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): no.We analyzed two of the three ¿pirs¿- lwas: k33714600282 [(b)(6)], sn (b)(6).[8840757].Also lwa with sn (b)(6) [(b)(6)] was analyzed as a reference for carryover.It was not possible to check also lwa k33714600630, it should be tested.All three lwas were checked for carry over and also for cell loss, using stained whole blood.Carryover off all checked systems was lower than 50 ppm, meet specification.Selective cell loss could not be detected with lysed whole blood in all three systems.Selective loss of monocytes/lymphocytes during preparation (duo-lyse with wash) pir3011628.
Event or Problem Description
It was reported that erroneous results were observed on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: 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): no.3.If patient samples were re-drawn, was there any change or delay of treatment? (go to question #4.): no.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): no.We analyzed two of the three ¿pirs¿- lwas: (b)(6) [pr (b)(4)], sn (b)(6) [(b)(4)].Also lwa with sn (b)(6) [pr (b)(4)] was analyzed as a reference for carryover.It was not possible to check also lwa (b)(6), it should be tested.All three lwas were checked for carry over and also for cell loss, using stained whole blood.Carryover off all checked systems was lower than 50 ppm, meet specification.Selective cell loss could not be detected with lysed whole blood in all three systems.Selective loss of monocytes/lymphocytes during preparation (duo-lyse with wash) (b)(4).
Additional Manufacturer Narrative
The following correction should be applied to the initial mdr: g.4.Date received by manufacturer: 2023-09-05 the following fields have been updated: g.1.Reporting office: (b)(6) g.2.Reporting office contact: (b)(6) g.4.Manufacturing site contact: (b)(6).H.6.Investigation summary: the customer reported a complaint regarding selective loss of monocytes/lymphocytes during preparation.Based on the investigation results, complaint was not confirmed, and the potential cause could not be determined.The field service representative (fsr) performed a service visit.The instrument was checked, and carryover protocol was performed.No cell loss was detected.It was confirmed that the device was working within specifications.Although the instrument was used for diagnostic testing, the issue was identified and resolved before the patient sample results were used for any diagnosis or treatment.Neither the customer nor any patients were harmed due to this issue.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.H3 other text : see h.10.

• 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: 17861700
• Report Number: 2916837-2023-00188
• Device Sequence Number: 6073598
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 09/22/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• 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