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

Catalog Number 337146

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

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

Event Date 09/05/2023

Event Type  malfunction  

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 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 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).

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
• Type of Device: 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
• MDR Text Key: 323717559
• Report Number: 2916837-2023-00181
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/16/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2012
• 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