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

Catalog Number 340922

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

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

Event Date 03/14/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: CD10 (HI10A) APC
• Type of Device: 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
• MDR Text Key: 340126457
• Report Number: 2647876-2024-00062
• Device Sequence Number: 1
• Product Code: MVU
• UDI-Device Identifier: 00382903409228
• UDI-Public: (01)00382903409228(11)230328(17)250228(10)3087869
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK230835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 340922
• Device Lot Number: 3087869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 08/26/2024
• Supplement Dates FDA Received: 08/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2023
• 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