MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. CD5 PE-CY7 CE

Catalog Number 348810

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

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

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown.The date received by manufacturer has been used for this field.Initial reporter prefix: (b)(6).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 while using the cd5 pe-cy7 ce that there was erroneous results.The following information was provided by the initial reporter 2) could you please inform us if samples are available? (customer mentioned: "in stock we have 2 more packs of cd5pecy7 from the same batch").As we said, we have 2 new packs of the same batch.3) was it obvious that the results were erroneous/could not be trusted? yes, because usually we don¿t need to make any change in the compensation matrix.4) is a confirmatory test always performed? we tested another new pack of the same batch that work properly for two weeks then even this one gave some problems in the compensation.It looks like the spillover of the pe-cy7 in the pe channel gradually increases.5) were patient samples involved? we work on primary samples from whole blood of cll patients.We perform an immunophenotype to characterize the cll for both diagnostic and research purposes.6) were erroneous results reported to the clinician? no, clinical markers could be evaluated through compensation.However it was difficult to evaluate the signal in the pe channel, in particular for some markers expressed at low intensity (for research purposes).7) were patients treated based on erroneous results? no.This is to inform you that we have encountered problems in detecting the fluorescence signal in 2 packs of cd5pecy7 cod 348810 lot: 2214258.With the first package, the problem occurred on first use.The second package, in use since 10.01.2023, gave no problems until yesterday but today it was necessary to change the compensation values during the analysis.In stock we have 2 more packs of cd5pecy7 from the same batch.

Event Description

It was reported that while using the cd5 pe-cy7 ce that there was erroneous results.The following information was provided by the initial reporter.2) could you please inform us if samples are available? (customer mentioned: "in stock we have 2 more packs of cd5pecy7 from the same batch") as we said, we have 2 new packs of the same batch.3) was it obvious that the results were erroneous/could not be trusted? yes, because usually we don¿t need to make any change in the compensation matrix.4) is a confirmatory test always performed? we tested another new pack of the same batch that work properly for two weeks then even this one gave some problems in the compensation.It looks like the spillover of the pe-cy7 in the pe channel gradually increases 5) were patient samples involved? we work on primary samples from whole blood of cll patients.We perform an immunophenotype to characterize the cll for both diagnostic and research purposes.6) were erroneous results reported to the clinician? no, clinical markers could be evaluated through compensation.However it was difficult to evaluate the signal in the pe channel, in particular for some markers expressed at low intensity (for research purposes).7) were patients treated based on erroneous results? no this is to inform you that we have encountered problems in detecting the fluorescence signal in 2 packs of cd5pecy7 cod 348810 lot.2214258.With the first package, the problem occurred on first use.The second package, in use since (b)(6) 2023, gave no problems until yesterday but today it was necessary to change the compensation values during the analysis.In stock we have 2 more packs of cd5pecy7 from the same batch.

Manufacturer Narrative

The following fields have been updated with corrected information: g.1 - reporting office - becton dickinson and company bd biosciences san jose ca, 95131.(b)(6).H.6 - imdrf annex f code - f26.Investigation summary: based on the investigation results, the reported issue of problems detecting the fluorescence signal was confirmed.Investigation results that were performed on the indicated failure mode were the following: based on the retain sample testing of part 91-0539 and lot 2207977 (lower level for 348810, lot 2214258), the results were as follows: 1.Fluorometry a.Fluorescence of test compared to reference = 18% (specification at release= fluorescence of test must be -40% to +80% of reference) b.Ratio of spillover (ros) = 3.77 (specification at release= pe-cy7 ros (ratio of spillover =1.38) 2.Analytical gel filtration chromatography (agfc) = 19% (specification at release = rpe-cy7 peak area must be =20% of conjugate) 3.Functional test ¿ antibody detected the intended population.Manual compensation adjustment was required to correct for spillover and optimize test.Based on batch history record (bhr) review, the results were as follows: bhr part 348810 lot 2214258 was reviewed.Manufacture started on 04aug22 and was completed on 09aug22; 256 eaches were manufactured.The material met all the manufacturing specifications prior to release.In addition, batch record for the lower part 91-0539, lot 2207977 was also reviewed.Manufacture of the lower part started on 27jul22 and was completed on 28jul22.The materials met all the manufacturing specifications prior to release.Potential cause was a usage error.Ifu # 23-5049 (09), product instructions for use does caution the user that some pe-cy7 conjugates show changes in their emission spectra with prolonged exposure to paraformaldehyde or light.To confirm resolution with the customer, 3 documented attempts were made to the customer without reply.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: CD5 PE-CY7 CE
• Type of Device: NA
• 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: 16526625
• MDR Text Key: 311581403
• Report Number: 2647876-2023-00007
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/06/2024

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: 07/31/2023
• Device Catalogue Number: 348810
• Device Lot Number: 2214258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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