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
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 carryover was observed on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: 2023-09-08: additional information based on fse¿s email: we analyzed two of the three ¿pirs¿- lwas: (b)(6), (b)(4), sn (b)(6), (b)(4).Also lwa with sn (b)(6), (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.A kappa-apc positive population was found in a sample tube during acquisition, but sample has not such population (seen in repeated preparation) pir3011629.
Event or Problem Description
It was reported that carryover was observed on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: 2023-09-08: additional information based on fse¿s email: we analyzed two of the three ¿pirs¿- lwas: (b)(6) [(b)(4)], sn (b)(6) [8840757].Also lwa with sn (b)(6) [(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.A kappa-apc positive population was found in a sample tube during acquisition, but sample has not such population (seen in repeated preparation) (b)(4).
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.Customer reported, ¿carryover off all checked systems was lower than 50 ppm, meet specification." fse also confirmed onsite that carryover was (b)(4) and instrument works within specification.Therefore this is not considered to be a reportable malfunction.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17761931
• Report Number: 2916837-2023-00181
• Device Sequence Number: 12515295
• 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): 12/05/2023

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 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: 09/05/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 09/16/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2012
• 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