MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD MULTITEST¿ TBNK W/TRUCOUNT; COUNTER, DIFFERENTIAL CELL

Model Number	662995
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while testing patient sample with 2 kits of bd multitest¿ tbnk w/trucount significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Both were on the same patient, there was no report of impact to the patient.The following information was provided by the initial reporter: 2 kits from lot #30568 have be found questionable dot plots, a significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Both of them are used the same patient edta blood for staining.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while testing patient sample with 2 kits of bd multitest¿ tbnk w/trucount significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Both were on the same patient, there was no report of impact to the patient.The following information was provided by the initial reporter: 2 kits from lot #30568 have be found questionable dot plots, a significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Both of them are used the same patient edta blood for staining.
Additional Manufacturer Narrative
H.6.Investigation: scope of issue and problem statement: customer (department of health, taiwan) reported that two kits of product 662995 (6-color tbnk reagent with trucount tubes) lot 30568 have questionable dot plots, a significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other kit from the same lot.Customer attached data files, for the ¿questionable¿ kit and from the ¿normal¿ kit also, customer stated that both kits used the same patient edta blood for staining when claim initiated 17-november-21.O manufacturing defect trend: product 662995 (6-color tbnk reagent with trucount tubes) lot 30568 was assembled in bdb san jose ca (plant 1149) using subassembly 91-0717 (bd multitest 6-color tbnk) lot 0315504, manufactured in bdb cayey (plant 1157).Material 91-0717 batch 0315504 was used to manufacture the following materials and corresponding lots: ¿ 662995 lot 30568 (177 ea) ¿ 337166 lot 30559 (1,450 ea) ¿ 662967 lot 30570 (1,057 ea) ¿ 644611 lot 30583 (1,050 ea) subassembly 91-0717 batch 0315504 was manufactured according to requirements and met manufacturing and qa acceptance criteria for release.No discrepancies (oos or qn) were identified in manufacturing/testing batch history record (bhr) of subassembly 91-0717 batch 031550 during evaluated period of 17-november-20 to 17-november-21.O root cause analysis: root cause cannot be determined.Customer indicates product 662995 (6-color tbnk reagent with trucount tubes) lot 30568 have questionable dot plots, a significant debris was seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Data provided by customer was evaluated, product-stained lymphocyte population as expected, and no performance problem observed.¿ complaint history review: the material 91-0717 batch 0315504, was further used in 4 lots of 4 different trucount related kits, including material 662995 batch 30568.Two complaints have been documented against material 91-0717 batch 0315504: 1) pr# 3978555, for product 662995 (6-color tbnk reagent with trucount tubes) lot 30568, and 2) pr# 3052549-gc, for product 337166 (bd multitest 6-color tbnk kit w/trucount) lot 30559, which both used the same subassembly material 91-0717 batch 0315504 as evaluated in the trackwise system for the period of 17-november-20 to 17-november-21.The investigation of complaint pr# 3052549-gc did not confirm the claim which included retain testing of subassembly 91-0717 lot 0315504, which confirmed product performed as per bd specifications.It is noted there is no additional complaints reported against product 662995 lot 30568 from a total of 177 ea sold to market or any other products manufactured using subassembly 91-0717 batch 0315504: ¿ 337166 lot 30559 (1,450 ea) ¿ 662967 lot 30570 (1,057 ea) ¿ 644611 lot 30583 (1,050 ea) ¿ risk review: risk analysis applicable for product 662995 (6-color tbnk reagent with trucount tubes) is available under risk analysis document 10000452372 ¿bd multitest and tritest device family, ivd devices risk analysis¿ (rev.06).Evaluation was based on use error hazard, which might trigger a problem to customer to properly perform testing while using reagent.Hazard(s) identified? x yes ¿ no reviewed item: 3.2.7.Use error hazard.Potential harmful effects: wrong result (potential patient harm) potential cause of failure: improper use of material by user: e.G dilution of reagent, age of blood, age of the stain.Severity: 3 probability: 2 risk index (ri): 6 risk evaluation: acceptable risk current controls: 1.Ifu will provide instructions on the proper use of the device.2.Control material would indicate there is a problem.3.Technical support service.Implementation verification: instruction for use (ifu).New hazard: none mitigation(s) enough x yes ¿ no ¿ batch history record (bhr) review: product 662995 (6-color tbnk reagent with trucount tubes) lot 30568 was assembled in bdb san jose ca (plant 1149) using subassembly 91-0717 (bd multitest 6-color tbnk) lot 0315504, manufactured in bdb cayey (plant 1157), which met established acceptance criteria for product release thru flow cytometry analysis, as demonstrated by evaluated batch history record (bhr) following quality control (qc) document qc91-0717.Manufacturing was performed according to requirements and met specifications without any discrepancy or nonconformance.¿ returned sample analysis: sample was not returned by the customer.Analysis was performed with picture of data provided by the customer.In addition, recent qa retain sample was tested functionally as part of a different investigation, in which results met bd specifications.¿ retain sample analysis: picture of data provided by the customer was analyzed.No retain sample testing deemed necessary.In addition, a recent qa retain sample was tested functionally as part of a different complaint investigation, in which results met bd specifications.¿ investigation summary: customer (department of health, taiwan) reported that two kits of product 662995 (6-color tbnk reagent with trucount tubes) lot 30568 have questionable dot plots, a significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Customer attached data files, for the ¿questionable¿ kit and from the ¿normal¿ kit also, customer stated that both kits used the same patient edta blood for staining when claim initiated 17-november-21.Data provided by customer was evaluated, and it was observed tbnk reagent product stained lymphocyte population as intended, without any performance problem observed.The customer complained about ¿significant debris¿ observed on cd45 vs ssc and cd19 vs ssc comparing with the other kit of 662995 from the same lot.Such debris raised by customer on observed data is not related to product performance but likely to sample preparation, as it was clearly visible out of the stained and gated lymphocyte population on the dot plot.Lymphocyte staining profile from customer provided data were comparable between ¿questionable¿ kit vs the ¿normal¿ kit without discrepancy in staining profile and actual t, b, and nk cell percent positive cells.Product 662995 lot 30568 was manufactured using subassembly 91-0717 (bd multitest 6-color tbnk) lot 0315504, manufactured in bdb cayey (plant 1157).Evidence demonstrates manufacturing process was performed according to requirements; product met release specifications without discrepancy and later used satisfactorily as reference lot for qc release test of newer subassembly 91-0717 batch 0336714.Although a root-cause for reported customer problem of debris on analyzed samples cannot be confirmed, it is noted that indications for proper staining of cells and acquiring samples are described under ifu 23-19817-01 (rev.1/2021), for product 662995 (6-color tbnk reagent with trucount tubes).Herein it is recommended to adjust the threshold to minimize debris and ensure populations of interest are included¿.In addition, at the troubleshooting section, problem of ¿the resolution between debris and cells is poor¿ is mentioned and two different possible causes are mentioned.Based on investigation performed, it is determined product 662995 (6-color tbnk reagent with trucount tubes) lot 30568 performs as intended, claim is not confirmed hence no further actions are deemed necessary at this time.¿ conclusion: product 662995 (6-color tbnk reagent with trucount tubes) lot 30568 manufactured using subassembly 91-0717 (bd multitest 6-color tbnk) lot 0315504, performs as intended and complies with bd specifications.Based on investigation performed it is determined claim is not confirmed and no further actions are necessary at this time.
Event or Problem Description
It was reported that while testing patient sample with 2 kits of bd multitest¿ tbnk w/trucount significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Both were on the same patient, there was no report of impact to the patient.The following information was provided by the initial reporter: 2 kits from lot #30568 have be found questionable dot plots, a significant debris were seen on cd45 vs ssc and cd19 vs ssc comparing with the other from the same lot.Both of them are used the same patient edta blood for staining.

• Brand Name: BD MULTITEST¿ TBNK W/TRUCOUNT
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12984329
• Report Number: 2647876-2021-00358
• Device Sequence Number: 5302287
• Product Code: GKZ
• UDI-Device Identifier: 00382906629951
• UDI-Public: 00382906629951
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K060375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 662995
• Device Catalogue Number: 662995
• Device Lot Number: 30568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown