MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD MULTITIEST¿; MULTITEST CD3/CD8/CD45/CD4W/TRUCOUNT CE

Catalog Number 342447

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

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

It was reported that while using the bd multitiest¿ that the customer has a lot of test tubes that sometimes gives expected, sometimes do not.The following information was provided by the initial reporter: we have another lot of test tubes (22103) which sometimes gives expected results, sometimes not.I'll add that file as well.I also added the acceptable ranges of the control sample there.The same ranges apply to pre-shipped iqc calibur controls.Safety alignment check to clarify the response in the patient impact.Patient impacted? - yes patient impact description ? absolute amounts of patient samples were not true.Were erroneous results reported to the clinician? no, because we did not send out the false results.Were patients treated based on erroneous results? no false results were sent out.If yes, was there any negative impact on patient health? no false results were sent out.

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

It was reported that while using the bd multitiest¿ that the customer has a lot of test tubes that sometimes gives expected, sometimes do not.The following information was provided by the initial reporter: we have another lot of test tubes (22103) which sometimes gives expected results, sometimes not.I'll add that file as well.I also added the acceptable ranges of the control sample there.The same ranges apply to pre-shipped iqc calibur controls.Safety alignment check to clarify the response in the patient impact.Patient impacted? yes, patient impact description ? absolute amounts of patient samples were not true.Were erroneous results reported to the clinician? no, because we did not send out the false results.Were patients treated based on erroneous results? no false results were sent out.If yes, was there any negative impact on patient health? no false results were sent out.

Manufacturer Narrative

H.6: ¿ scope of issue: the scope of the issue is limited to pn342447 and ln 22998, multitest cd3/cd8/cd45/cd4 w/ trucount tubes.Problem statement: event occurred in estonia on oct 21, 2022 with stained multicheck control sample result can sometimes be within or out of the multicheck control sample expected range.Erroneous results were not sent to the clinician, and no impact on patient's treatment, health and safety.Investigation summary: ¿ manufacturing defect trend: there are zero number of qns here related to the reported issue.Date ranges from 18 oct 2021 to date 18 oct 2022.Related qn(s): na ¿ batch history record (bhr) review: bhr part 32447, lot 22998 was reviewed.Bhr part 91-0482, lot 70310 was reviewed.Bhr part 91-0786, lot 22103 was reviewed.The materials met all the manufacturing specifications prior to release.¿ complaint history review: there are 4 of complaints related to the reported complaint.Date ranges from 18 oct 2021 to date 18 oct 2022).There are 4 complaints related to the reported issue, (b)(4) (this complaint) and (b)(4).¿ the retain sample pn/ln 342447- 22998 was tested and evaluated.The result of the 5 tubes were within the expected range of the multicheck control sample.Retain testing analysis file name (b)(4).¿ returned sample analysis: received was a copy of the customer¿s results which showed that cells/ul of t cell subset population values were not within the expected values of the multicheck control sample.Risk review: for risk analysis review, bd multitest and tritest device family ivd devices risk analysis, doc#(b)(4), revision 07 was reviewed.Hazard identified? yes ¿ hazard id#: 3.2.17 ¿ hazard: use error hazard.¿ cause: an incorrect low count of cd3+, cd3+cd8+, cd3+cd4+cd8+, cd16+cd56+, cd19+, or cd45+ could occur if the user dispensed a smaller volume of sample into the assay than intended.¿ harmful effects: wrong result (potential patient harm), patient with normal cd3+, cd3+cd8+, cd3+cd4+cd8+, cd16+cd56+, cd19+, or cd45+ cell count may result in the patient receiving ineffective treatment.¿ residual severity: 3 ¿ residual probability: 1 ¿ residual risk index: 3 ¿ potential causes: ¿ based on the investigation results, the potential cause was not determined.¿ investigation result / analysis: the investigation was performed and based on bhr and the product the product met all the acceptance criteria, and retain reagent sample test results were within the expected range of the multicheck control sample.¿ conclusion: based on the investigation result, root cause was not confirmed.Retain sample of the reagent was tested and evaluated and the results were within the expected range of the multicheck control values.The values obtained by the customer using multicheck control was not within the expected range, therefore obtained erroneous results.Although the customer obtained erroneous results , the false results was not reported to the clinician, patient was not treated based erroneous results and there no negative impact on patient health or safety.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.¿ supporting document: (b)(4).

• Brand Name: BD MULTITIEST¿
• Type of Device: MULTITEST CD3/CD8/CD45/CD4W/TRUCOUNT CE
• 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: 15667488
• MDR Text Key: 307108512
• Report Number: 2916837-2022-00322
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: EN
• 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: 07/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 342447
• Device Lot Number: 22998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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