MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. CD10 (HI10A) APC; REAGENTS, SPECIFIC, ANALYTE

Catalog Number	340922
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	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using cd10 (hi10a) apc erroneous results were obtained.Erroneous results were reported, however, there was no report of patient impact.The following information was provided by the initial reporter: false positive staining of cd10 apc (340922_3087869) on b cells by software hazard, injury or erroneous results details erroneous reporting of cd10+ follicular lymphoma on a patient sample that ihc identified as cd10- mantle cell lymphoma.Clinical fas optimized settings for v450 and added some label specific spillover controls.
Additional Manufacturer Narrative
Additional g5.Pma/510k: , k170974, k201814.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 field has been updated with corrected information: d.4.Unique identifier (udi) # : (b)(4).H.4.Device manufacture date: 28-mar-2023.H.6: based on the investigation results, the reported performance issue was not confirmed.Investigation results that were performed on the indicated failure mode were the following: batch history record (bhr) review and later material usage data as a reference batch showing acceptable performance.Customer response to follow-up questions revealed the reported problem was solved by re-installing the facsuite software.Potential cause for customer reported complaint was not determined.The customer stated that after reinstalling the facsuite software they have not seen this issue with cd10 or any other antibodies at this time.The customer also received a free of charge order.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 cd10 (hi10a) apc erroneous results were obtained.Erroneous results were reported, however, there was no report of patient impact.The following information was provided by the initial reporter: false positive staining of cd10 apc (340922_3087869) on b cells by software hazard, injury or erroneous results details erroneous reporting of cd10+ follicular lymphoma on a patient sample that ihc identified as cd10- mantle cell lymphoma.Clinical fas optimized settings for v450 and added some label specific spillover controls.

• Brand Name: CD10 (HI10A) APC
• Common Device Name: REAGENTS, SPECIFIC, ANALYTE
• 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: 19047377
• Report Number: 2647876-2024-00062
• Device Sequence Number: 8565981
• Product Code: MVU
• UDI-Device Identifier: 00382903409228
• UDI-Public: (01)00382903409228(11)230328(17)250228(10)3087869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK230835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 02/28/2025
• Device Catalogue Number: 340922
• Device Lot Number: 3087869
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• 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