MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD LEUCOCOUNT¿; COUNTER, DIFFERENTIAL CELL

Model Number	340523
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd leucocount¿ that there was incorrect label information.The following information was provided by the initial reporter: errors have crept into the new eifu, both in the english version and probably in all translations (at least the german one).In the manual instrument setup as well as in the measurement of the data on the calibur it is referred to that one should use the bd facscomp software.This is not correct.The bd facscomp software cannot do this, rather the bd cellquest pro software is used for this.(this is an error that was already partially present in the old technical datasheet and has probably not been improved).Page 8.To perform manual setup using bd facscomp¿ software: (must be bd cellquest pro software).Page 9.To acquire the samples using bd facscomp¿ software: (must be bd cellquest pro software).
Additional Manufacturer Narrative
E.4 initial reporter phone # (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated: g.1.Reporting office: (b)(6).H.6.Imdrf annex f grid: f26.H.6.Investigation summary: based on the investigation results, the reported issue of errors in the eifu for 340523 leucocount human reagent kit was confirmed.Investigation results that were performed on the indicated failure mode were the following: photos of efu 23-3434 (12) was reviewed and showed the following errors.On page 8 for running the assay on bd facs calibur flow cytometers, it states, ¿to perform manual setup using bd facscomp¿ software.¿ on page 9 for running the assay on bd facs calibur flow cytometers, it states, ¿to acquire the samples using bd facscomp¿ software.¿ the section of the eifu should state bd cellquest¿ pro software instead of bd facscomp¿ software.For the label review, the latest revision of the eifu in sap is 23-3434 (14) was reviewed.On page 8 for running the assay on bd facs calibur flow cytometers, it states, ¿to perform manual setup using bd facscomp¿ software.¿ this section still needs to be corrected from bd facscomp¿ software to bd cellquest¿ pro software in the future eifu release.On page 10 for running the assay on bd facs calibur flow cytometers, it states, ¿to acquire the samples using bd cellquest¿ pro software.¿ this section has been corrected.Bhr part # 340523 lot # 3101059 was reviewed.The product met all the manufacturing specifications prior to release.The potential cause of the errors of eifu was due to wrong software referenced for manual setup.The publications department has been notified and quality notification was initiated.This is the only complaint for eifu error.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 the bd leucocount¿ that there was incorrect label information.The following information was provided by the initial reporter: errors have crept into the new eifu, both in the english version and probably in all translations (at least the german one).In the manual instrument setup as well as in the measurement of the data on the calibur it is referred to that one should use the bd facscomp software.This is not correct.The bd facscomp software cannot do this, rather the bd cellquest pro software is used for this.(this is an error that was already partially present in the old technical datasheet and has probably not been improved).Page 8 to perform manual setup using bd facscomp¿ software: (must be bd cellquest pro software).Page 9 to acquire the samples using bd facscomp¿ software: (must be bd cellquest pro software).

• Brand Name: BD LEUCOCOUNT¿
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17172509
• Report Number: 2647876-2023-00051
• Device Sequence Number: 7200982
• Product Code: GKZ
• UDI-Device Identifier: 00382903405237
• UDI-Public: 00382903405237
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BK970046
• 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
• Report Date (Section B): 03/11/2024

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 Expiration Date: 01/31/2025
• Device Model Number: 340523
• Device Catalogue Number: 340523
• Device Lot Number: 3101059
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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