MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD CD15 FITC

Catalog Number 332778

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

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

Mdr  2916837-2022-00243 was initially reported to capture this issue and later patient identifiers were received.  this report is for patient 8 of 9.It was reported that while using the bd cd15 fitc that there were erroneous results.The following information was provided by the initial reporter: original event description: "we are experiencing problem with cd15 fitc ((b)(4) lot 2076505) on our two canto iis.We have tried with both instruments and it looks really weird in the v500 channel.I attached a document with images and more information on what we have tested.(when we do compensation setup on the instrument we use the strongest flourochrome for each channel.) since we use v500 for cd45 (and only cd45) it is very important for us to have a normal appearance in that channel.The antibody in question is recently opened and is fresh." afterwards, we received more information from customer who mentioned 11 patients id (email attached) - two first were captured in pr# (b)(4).(related record), the rest is in this pr.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Mdr  2916837-2022-00243 was initially reported to capture this issue and later patient identifiers were received.  this report is for patient 8 of 9.It was reported that while using the bd cd15 fitc that there were erroneous results.The following information was provided by the initial reporter: original event description: "we are experiencing problem with cd15 fitc (ref (b)(4), lot 2076505) on our two canto iis.We have tried with both instruments and it looks really weird in the v500 channel.I attached a document with images and more information on what we have tested.(when we do compensation setup on the instrument we use the strongest flourochrome for each channel.) since we use v500 for cd45 (and only cd45) it is very important for us to have a normal appearance in that channel.The antibody in question is recently opened and is fresh." afterwards, we received more information from customer who mentioned 11 patients id (email attached) - two first were captured in pr# (b)(4) (related record), the rest is in this pr.

Manufacturer Narrative

H6.Investigation summary: scope of issue: the scope of issue is limited to product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505.Problem statement: customer (b)(6) reported on 04-nov-22 that additional patient samples (total of 11 patient samples) were found with similar weird signal results using product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 in v500 channel on facs canto ii instrument while using cd15 fitc.Customers indicate two canto ii instruments were used, they have tried with both instruments, and it looks weird in the v500 channel.There¿s a note on intake internal bd comments this could be a reagent issue or a compensation issue.No additional details were provided related to troubleshooting outcomes or support provided.The first 2 patient samples having apparent weird results using this cd15 fitc product were reported and investigated on previous complaint, which was unconfirmed.Investigation summary: manufacturing defect trend: zero (0) quality notifications (qn) or nonconformance reports were found against product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 or subassembly 91-0297 batch 2033177, from evaluated date range of 04-nov-21 to 04-nov-22.Batch history record (bhr) review: product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 was assembled in bdb san jose (plant 1149) using subassembly 91-0297 batch 2033177, manufactured in bdb cayey pr (plant 1157), which was used to manufacture the following products: 1.332778 lot 2076505 (b)(4): all (b)(4) ea sold to market.2.347423 lot 2139478 (b)(4): (b)(4) sold to market.3.340703 lot 2139480 (b)(4): all (b)(4) sold to market.Qc bhr 91-0297 batch 2033177 was reviewed.Material met qc specifications: flow cytometry staining of k562 cell line, test vs ref log mean fluorescence (lmf) lot-to-lot variability = -8 lmf channels (spec +/- 60 channels), and % positive population = 95% (spec = 90%), prior to release.Material expires 31-aug-23.Subassembly 91-0297 batch 2033177 was later satisfactorily used on 20-jun-22 as a reference lot during qc testing of newer subassembly 91-0297 batch 2138725, meeting % positive population (test batch 2138725 = 100% and ref batch 2033177 = 100%) specifications without discrepancy.Complaint history review: two complaints reported from same customer (b)(6); against product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 having weird signal in v500 channel on facs canto ii instrument while using cd15 fitc.Customer from (b)(6) initially provided patient test sample information captured on previous complaint on 12-aug-22, then submitted additional patient test sample information on 04-nov-22 which was captured on current complaint.No additional complaints have been reported to date from a total of (b)(4) ea units sold to market of any of the three different catalog products/lots manufactured from same subassembly 91-0297 (cd15 fitc, clone mma) batch 2033177: (1) 332778 lot 2076505, (2) 347423 lot 2139478 and (3) 340703 lot 2139480.Date range evaluated 04-nov-21 to 04-nov-22.Retain sample analysis: the evaluation of the retain sample was not required because subassembly 91-0297 (cd15 fitc, clone mma) batch 2033177 was tested by flow cytometry as reference lot within six months (tested 20-jun-22) of previous complaint reported on 12-aug-22 and current complaint reported on 04-nov-22.Flow cytometry test demonstrate product meets specifications without discrepancy using k562 cell line, which is positive for cd15 marker.Returned sample analysis: the sample was not requested to be returned because flow cytometry release data was examined.Data evaluated demonstrates product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 tested under subassembly 91-0297 (cd15 fitc, clone mma) batch 2033177 performs as intended.Risk review: risk management file 100310ra (ra antibodies and antibody conjugates: ce-ivd products) rev.02 was reviewed.Hazard(s) identified? _x_yes / no.If no (to above), what actions will be taken? n/a.Hazard id#: _3.2.1 _.Hazard: _use error hazard_.Cause: _improper use: incorrect processing ( time ,temperature , volume, mixing )._ harmful effects: _ wrong result; not matching profile leading to customer inconvenience, i.E., additional testing required, cost and time ordelay of diagnosis._ residual severity: _2_.Residual probability: _3_.Residual risk index: _6 = as far as possible (afap)__.Potential causes: based on the investigation results, the potential cause was not determined.Based on data and evaluated records, it is determined product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 performs as intended.Investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, bhr data, and risk analysis, the potential cause of the performance issue of weird signal results in v500 channel for antibody product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 cannot be determined.Per ifu 23-6925-03, product 332778 (cd15 fitc, clone mma, ce-ivd) recognizes a marker present on greater than 95% of mature peripheral blood granulocytes and present at low density on circulating monocytes.Cd15 is absent from immature and mature resting peripheral blood and lymphoid tissue b and t cells, and nk cells.Cd15 is expressed on virtually all patients with chronic myelogenous leukemia and by 80% or more of leukemic blasts in a given acute myeloid leukemia (aml).Volume per test for cd15 fitc is 20 ¿l.Prior complaint investigation from same customer (b)(6) indicates product 332778 (cd15 fitc, clone mma, ce-ivd) lot 2076505 have weird signal in v500 channel while using cd15 fitc reagent along a mixture of other reagents combined by customer and investigation revealed they used 10 ul of reagent from a 1:8 dilution mixture.No detailed step-by-step process described of how product was used for staining along other reagents in mixture prepared or how compensation performed.Product 332778 (cd15 fitc, clone mma, ce-ivd) label and instruction for use (ifu) 23-6925(05) indicates to use appropriate volume of monoclonal antibody to 100 ul of whole blood as indicated in vial label.Vial label for this product indicates to use 20 ul of reagent for staining samples, but customer used 10 ul of a 1:8 dilution instead, which is suboptimal dilution and volume for staining samples using cd15 fitc reagent.It is noted there is no v500 product or related conjugate format manufactured at bdb cayey pr (plant 1157) where product 332778 lot 2076505 was manufactured from purification to fitc conjugation and final formulation stage to potentially cause a contamination exposure with a v500 fluorochrome substance.Conclusion: based on the investigation result, complaint was not confirmed and no further actions deemed necessary at this time.

• Brand Name: BD CD15 FITC
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15755495
• MDR Text Key: 307701524
• Report Number: 2916837-2022-00337
• Device Sequence Number: 1
• Product Code: MVU
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 06/23/2023

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: 08/31/2023
• Device Catalogue Number: 332778
• Device Lot Number: 2076505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1