MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES HU CD38 BV510 HIT2 50TST

Catalog Number 563251

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that erroneous results were found while using the antibody hu cd38 bv510 hit2 50tst.There was no delay in treatment or patient impact.The following information was provided by the initial reporter.¿customer observed a possible issue with the anti-cd38 bv510 antibody with the presence of debris/particles, which saturate the cd38 population (results in bad resolution).The first time the customer experienced this was on (b)(6) 2020 in 3 samples.For the 3rd sample they verified the run on another flow cytometer to exclude instrument issues.".

Event Description

It was reported that erroneous results were found while using the antibody hu cd38 bv510 hit2 50tst.There was no delay in treatment or patient impact.The following information was provided by the initial reporter.¿customer observed a possible issue with the anti-cd38 bv510 antibody with the presence of debris/particles, which saturate the cd38 population (results in bad resolution).The first time the customer experienced this was on 19/11/20 in 3 samples.For the 3rd sample they verified the run on another flow cytometer to exclude instrument issues".

Manufacturer Narrative

H6: investigation summary scope of issue: the scope is limited to cat# 563251 lots 9336119 and 0261863 (hu cd38 bv510 hit2 50tst).Problem statement: aggregation/high background.The customer states they are seeing aggregation when using hu cd38 bv510 hit2 antibody mat 563251 lots 9336119 and 0261863 and it is saturating the cd38 population when used to test patient samples.This was observed in a total of 3 patient samples.Samples were run on a second lyric flow cytometer and aggregation was still seen.This excluded instrument issues as a cause of the aggregation.The customer claims they have been using the same 10 color myeloma panel for 2 years and this was the first time they had a problem with aggregation and mat 563251 hu cd38 bv510 hit2.A centrifugation step of the reagent and elimination of the pellet corrected the error.Manufacturing defect trend: a historical review was performed and there are 2 manufacturing nonconforming (qn) records in sap related to halb 51-545-9008921 hu cd38 bv510 bulk hit2 from nov 2019 to jan 2021.The 2 qns are 200879483 mat# 51-545-9008921 lot 0091596 for high background and 200888474 mat# 51-545-9008921 lot 0134443 for high aggregation/background.Both halbs batches on qn, were rejected and scrapped.Complaint trend: there are 2 complaints related to the cat# 563251 from nov 2019 to jan 2021, which is complaint 2261526 and 2109080 (the current complaint) from the same customer also for seeing aggregation in lot 9336119.Batch history record (bhr) review: the batch records for mat# 51-545-9008921 lot 9092995 and lot 0190289 (hu cd38 bv510 bulk hit2) were reviewed and met all the manufacturing and quality control specifications prior to release.There are no indications of any abnormality nor deviation during its manufacture.Retain sample evaluation / testing: retain samples of 563251 lots 9336119 and 0261863 hu cd38 bv510 hit2 were sent to the product support team for testing.See ¿investigation results/analysis¿ section for qa retain test results.Returned sample evaluation: no customer samples were returned but the customer did attach data for 563251 lot#0261863 (no data from the customer for lot#9092995) showing the aggregation in their results when using cat# 563251 b#s 9336119, 0261863.Their data also showed decreased aggregation when used after spinning the vial.Investigation result / analysis: the product support group evaluated the complaint fert 563251 lot 9336119 was made from halb mn 51-545-9008921 batch 9092995 and lot 0261863 was made from halb batch 0190289.The qa fert retains were evaluated in comparison with their respective parent halb batches obtained from oc reference inventory and spun down samples of both fert lots.The fert, both vortexed and spun down, and halb samples were tested at 2.0, 1.0, 0.5, and 0.25 ug per test using a lysed whole blood model system.All samples demonstrated correct staining profiles on the lymphocyte and monocytes populations while granulocytes were negative, as expected.The fert complaint lots 9336119 and 0261863 demonstrated very similar % positive staining with equivalent mfi of the positive lymphocytes and monocytes.No significant aggregation, i.E.Extra bright, events were observed with any of the inspected samples, either fert versus halb or vortexed versus spun down.Based upon these results the customer issue could not be replicated and their complaint could not be confirmed.Risk analysis: the reagent products produced from the bd biosciences san diego plant are labeled as research use only, which means that these products are not certified by the regulatory bodies for use within clinical settings and for diagnostic use.Additionally, bdb san diego manufacturing plant is certified and compliant to iso 9001:2015.Under this international standard a risk-based approach is required as part of risk analysis.Specifically, section 6.1.2 of iso 9001:2015 states that the organization shall plan actions to address risks and opportunities.Additionally, section a.4 provides clarification that no requirement for formal methods for risk management or documented risk management process is required.In other words, risk management file is not required per iso 9001:2015.Risk management methodology may not need to be a formal process fmea (pfmea).As a result, risk management file has not been maintained for the ruo reagent product which is part of this customer complaint.To comply with sop5011-18 rev 12 section 5.1.12 requirement, a risk analysis methodology customer complaint related to ruo reagent will be based on the risk ranking will be based on cpr-028a capa initiation determination (cid) form.The complaint severity is negligible (s1) as there is some customer dissatisfaction, but no impact to the quality system along with an occurrence ranking of improbable (o1) as this is the first customer to complain about seeing aggregation when using cat.No.563251 (hu cd38 bv510 bulk hit2), with the complaint claim concluding to be not confirmed.The severity is limited (s2) and the impact is limited as the complaint was not confirmed.Root cause: bv510 dye lots 964, 1655 and 1533 may be prone to aggregation.However no root cause was determined as the complaint issue was not replicated or confirmed.Conclusion: based on the investigation results, the complaint was unconfirmed as the reagent performs as expected when tested using our model system.See h10.

• Brand Name: HU CD38 BV510 HIT2 50TST
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11060540
• MDR Text Key: 247660935
• Report Number: 2916837-2020-00323
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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: 09/30/2021
• Device Catalogue Number: 563251
• Device Lot Number: 9336119
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1