MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD MULTITEST IMK KIT; COUNTER, DIFFERENTIAL CELL

Model Number 340503

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

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 bd multitest imk kit resulted in erroneous results on patient samples.The following information was provided by the initial reporter: "the % of cd19 in the analyzed samples are lower than expected.However, in the multicheck control the percentages are correct.The samples were patient samples but there was no impact and no harm on the patients, since the erroneous results have not been used.".

Manufacturer Narrative

H6: investigation summary scope of issue: the scope of the issues is limited to 340503 ¿ 99022, bd multitest imk kit.Problem statement: the % of cd19 in the analyzed samples are lower than expected.However, in the multicheck control the percentages are correct.Manufacturing defect trend: there is 1 qn¿s reported for this product.Date range 11/09/2020 to 11/09/2021 for 340503-99022, bd multitest imk kit.Root cause analysis: based on the investigation result, the customer complaint was not confirmed.Complaint history review: there was 1 reported performance complaints including this pr#: (b)(4).Date from 11/09/2020 to 11/09/2021.Risk review for risk analysis review, bd multitest and bd tritest device family ivd devices risk analysis, version 06 was reviewed.Hazard(s) identified? yes; no.Hazard #: 3.2.17 hazard: use error hazard 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.Severity: 3; probability: 1; risk index: 3; risk control: ifu states how critical the volume of the sample is to the function of the assay.Control material could indicate there is a problem.Implementation: ifu; effectiveness: verified by the label approval process; pms review confirms the risk controls.New hazard: none; mitigation(s) sufficient yes.If no (to above), what actions will be taken? na.Batch history record (bhr) review: the following batch records were reviewed.340503 ¿ 99022 multitest imk kit; 340500 - 65431 multi test cd3/cd16+cd56/cd45/cd19; 91-0481- 0280061 multi test cd3/cd16+cd56/cd45/cd19; all materials passed all the manufacturing specification prior to release.Returned sample analysis no performance results or photos were received from the customer.Investigation of the complaint was conducted by historical batch record review and retain sample testing.Retain sample analysis: a vial of the complaint (lot# 99022) and reference (lot#36424) from the imk kit that contain cd3/cd16+cd56/cd45/cd19 antibodies were used to stain two normal donors.Staining was performed in a trucount tube to determine the absolute count and percentage of cd19 for both reagent samples.The stained samples were acquired in the canto ii clinical software for multitest.The absolute count and percentage results of cd19 between the complaint and reference reagent samples for the two donors were comparable.Therefore the complaint was not confirmed.See attached ppp entitled parent id# (b)(6).Conclusion: based on the investigation result: the customer complaint was not confirmed.Investigation conclusion: based on the investigation result, complaint was not confirmed.H3 other text : see h10.

Event Description

It was reported that bd multitest imk kit resulted in erroneous results on patient samples.The following information was provided by the initial reporter: "the % of cd19 in the analyzed samples are lower than expected.However, in the multicheck control the percentages are correct.The samples were patient samples but there was no impact and no harm on the patients, since the erroneous results have not been used.".

• Brand Name: BD MULTITEST IMK KIT
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12824132
• MDR Text Key: 280954564
• Report Number: 2916837-2021-00443
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903405039
• UDI-Public: 00382903405039
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K980858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 340503
• Device Catalogue Number: 340503
• Device Lot Number: 99022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1