MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. CD19 PE-CY7 CE; ANALYTE SPECIFIC REAGENTS

Catalog Number 341113

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

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

It was reported that during use with cd19 pe-cy7 ce erroneous results were obtained.Results were not reported and there was no impact to patient.The following information was provided by the initial reporter: 341113, cd19pe-cy7 appears to be non-functional 1.Were patient samples involved? the product was used on a sample from a patient.2.Was it obvious that the results were incorrect/could not be considered reliable? it was evident that the results were incorrect and could not be considered reliable.3.Is a confirmatory test always performed? we performed a repeat with the same product and repeated with a different one.4.Have the incorrect results been communicated to the doctor? incorrect results have not been communicated to the doctor.

Manufacturer Narrative

G.5.The event described occurred on an asr ce marked reagent, however, it is considered to be substantially similar to the legally u.S.Marketed reagent (341103).The us reagent 510k (exempt) has been reported.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with cd19 pe-cy7 ce erroneous results were obtained.Results were not reported and there was no impact to patient.The following information was provided by the initial reporter: 341113 cd19pe-cy7 appears to be non-functional.1.Were patient samples involved? the product was used on a sample from a patient 2.Was it obvious that the results were incorrect/could not be considered reliable? it was evident that the results were incorrect and could not be considered reliable 3.Is a confirmatory test always performed? we performed a repeat with the same product and repeated with a different one.4.Have the incorrect results been communicated to the doctor? incorrect results have not been communicated to the doctor.

Manufacturer Narrative

H.6: based on the investigation results, the reported performance issue against product 341113 (cd19 pe-cy7) lot 3163258 was not confirmed.Customer did not answer specific questions or provide additional information requested aimed to understand reported problem and determine possible cause(s), hence a possible cause for reported problem could not be determined.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.

• Brand Name: CD19 PE-CY7 CE
• Type of Device: ANALYTE SPECIFIC REAGENTS
• 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: 18570960
• MDR Text Key: 333604715
• Report Number: 2647876-2024-00014
• Device Sequence Number: 1
• Product Code: MVU
• UDI-Device Identifier: 00382903411139
• UDI-Public: (01)00382903411139
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 341113
• Device Lot Number: 3163258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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