MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES FACSCANTO¿ 10 COLOR CONFIGURATION; FLOW CYTOMETER

Catalog Number 657338

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2019

Event Type  Injury  

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

This report represents patient 3 of 4: it was reported that while performing tests with a facscanto¿ 10 color configuration, patient data was exported from the instrument as a.Csv file (comma separated variables file) in an unusual format.Reportedly, the exported file did not properly separate individual data entries with commas into separate columns of the file and all data points were placed in the same column.The lab technician converted the original file into a tab delimited.Txt file (text file) using the third party application microsoft excel.The new file was sent to the forth party (b)(6) results workstation where erroneously calculated results were assigned to four separate patients.This resulted in patients being assigned results for the following tests that were inconsistent with results from the facscanto¿ 10 color configuration instrument generated reports: cd3+ % (percentage); cd3+cd4+ % (percentage); cd3+cd4+ abs (absolute value); cd3+cd8+ % (percentage); cd4+cd8+ ratio; cd16/56+ % (percentage); cd3-cd19+ % (percentage).Generalized results were provided highlighting significant differences between the results reported by the facscanto¿ 10 color configuration and the results that were assigned to patients through the hospital¿s workflow as well as a.Csv file containing mis-formatted data.No specific information was provided regarding which patients received which test results and what impact this had on their course of treatment.On follow up it was not possible to obtain information linking specific patient identifiers to specific test results.There was no indication that erroneous results led to a misdiagnosis or a deterioration of the patients¿ condition.

Manufacturer Narrative

This report represents patient 3 of 4: it was reported that while performing tests with a facscanto¿ 10 color configuration, patient data was exported from the instrument as a.Csv file (comma separated variables file) in an unusual format.Reportedly, the exported file did not properly separate individual data entries with commas into separate columns of the file and all data points were placed in the same column.The lab technician converted the original file into a tab delimited.Txt file (text file) using the third party application microsoft excel.The new file was sent to the forth party sunquest laboratory labaccess results workstation where erroneously calculated results were assigned to four separate patients.This resulted in patients being assigned results for the following tests that were inconsistent with results from the facscanto¿ 10 color configuration instrument generated reports.The following data was provided indicating the correct and erroneous values associated with the patient record: patient 3: incorrect cd3+ %826; correct %86.1, #5713.15.Incorrect cd3+/cd4+ %4448.8; correct %17.8, #1182.51.Incorrect cd3+/cd4+ #18; correct %1182.5, #1182.51.Incorrect cd3+/cd8+ %5713.2; correct %67, #4448.81.Incorrect cd4+: cd8+ ratio 6637.5; correct %1.8, #122.17.Incorrect cd16/56+ %122.2; correct %7.6, #505.97.Incorrect cd19+ %506.3; correct %5.6, #372.27.Incorrect cd45+ %99.3; correct %99.3, #6637.49.There was no indication that erroneous results led to a misdiagnosis or a deterioration of the patient¿s condition.The following data was provided indicating the correct and erroneous values associated with the patient record: patient 3: incorrect cd3+ %826; correct %86.1, #5713.15.Incorrect cd3+/cd4+ %4448.8; correct %17.8, #1182.51.Incorrect cd3+/cd4+ #18; correct %1182.5, #1182.51.Incorrect cd3+/cd8+ %5713.2; correct %67, #4448.81.Incorrect cd4+: cd8+ ratio 6637.5; correct %1.8, #122.17.Incorrect cd16/56+ %122.2; correct %7.6, #505.97.Incorrect cd19+ %506.3; correct %5.6, #372.27.Incorrect cd45+ %99.3; correct %99.3, #6637.49.

Event Description

This report represents patient 3 of 4: it was reported that while performing tests with a facscanto¿ 10 color configuration, patient data was exported from the instrument as a.Csv file (comma separated variables file) in an unusual format.Reportedly, the exported file did not properly separate individual data entries with commas into separate columns of the file and all data points were placed in the same column.The lab technician converted the original file into a tab delimited.Txt file (text file) using the third party application microsoft excel.The new file was sent to the forth party sunquest laboratory lab access results workstation where erroneously calculated results were assigned to four separate patients.This resulted in patients being assigned results for the following tests that were inconsistent with results from the facscanto¿ 10 color configuration instrument generated reports.The following data was provided indicating the correct and erroneous values associated with the patient record: patient 3: incorrect cd3+ %826; correct %86.1, #5713.15.Incorrect cd3+/cd4+ %4448.8; correct %17.8, #1182.51.Incorrect cd3+/cd4+ #18; correct %1182.5, #1182.51.Incorrect cd3+/cd8+ %5713.2; correct %67, #4448.81.Incorrect cd4+: cd8+ ratio 6637.5; correct %1.8, #122.17.Incorrect cd16/56+ %122.2; correct %7.6, #505.97.Incorrect cd19+ %506.3; correct %5.6, #372.27.Incorrect cd45+ %99.3; correct %99.3, #6637.49.There was no indication that erroneous results led to a misdiagnosis or a deterioration of the patient¿s condition.

Manufacturer Narrative

Investigation: it was reported that while performing tests with a facscanto¿ 10 color configuration, patient data was exported from the instrument as a.Csv file (comma separated variables file) in an unusual format.Reportedly, the exported file did not properly separate individual data entries with commas into separate columns of the file and all data points were placed in the same column.The lab technician converted the original file into a tab delimited.Txt file (text file) using the third party application microsoft excel.The new file was sent to the forth party sunquest laboratory labaccess results workstation where erroneously calculated results were assigned to four separate patients.This resulted in patients being assigned results for the following tests that were inconsistent with results from the facscanto¿ 10 color configuration instrument generated reports.The following data was provided indicating the correct and erroneous values associated with the patient record: patient 3: incorrect cd3+ %826; correct %86.07, #5713.15.Incorrect cd3+/cd4+ %4448.8; correct %17.82, #1182.51.Incorrect cd3+/cd4+ #18; correct %1182.51, #1182.51.Incorrect cd3+/cd8+ %5713.2; correct %67.03, #4448.81.Incorrect cd4+: cd8+ ratio 6637.49; correct %1.84, #122.17.Incorrect cd16/56+ %122.2; correct %7.62, #505.97.Incorrect cd19+ %506.3; correct %5.61, #372.27.Incorrect cd45+ %99.3; correct %99.3, #6637.49.Generalized results were provided highlighting significant differences between the results reported by the facscanto¿ 10 color configuration and the results that were assigned to patients through the hospital¿s workflow as well as a.Csv file containing mis-formatted data.No specific information was provided regarding which patients received which test results and what impact this had on their course of treatment.On follow up it was not possible to obtain information linking specific patient identifiers to specific test results.There was no indication that erroneous results led to a misdiagnosis or a deterioration of the patient¿s condition.Manufacturing defect trend: qns (zm, ze) related to this issue in sap from 01jan2018 to 31jan2019 = 0.The defect was identified as a file saving defect and not related to instrument or software.A search for similar manufacturing defects from 01jan2018 to 31jan2019 did not identify any defect trends.Device history record (dhr) review: a review of the dhr for facscanto p/n657338, s/n# (b)(4) indicates the instrument functioned as intended when leaving the factory.No issues related to this failure mode were identified.Complaint trend: based on complaint data from 01jan2018 to 31jan2019, there are 4 complaints.All 4 related complaints originated from a single instrument, there are no reported complaints observed from jan 2018 to jan 2019, indicated a single data point, no trend detected.Failure analysis: reviewed from the customer csv files, screen shots and cd4 count data summary.Upon review it was observed that the customer was not using the becton dickinson recommended / approved facslink file saving system.Investigation result / analysis: the facscanto clinical software performed as expected resulting in a correct test print out.The file was saved as a.Txt file and not as the recommended.Csv file when these files were transferred using a third party middleware system (data innovation), the csv file was corrupted, all information resided in one active cell when opened via csv file format.This issue is related to the customer¿s file exporting method.This type of failure involves file exporting/saving method of the user wherein a third party middleware system (data innovation) not provided by bd was being utilized.Facslink is the becton dickinson recommended and validated file exporting/saving system.A series of troubleshooting efforts have been made but were unable to recreate the file exporting /saving error.It was suggested to reinstall the software to restore all default file export.

Event Description

It was reported that while performing tests with a facscanto¿ 10 color configuration, patient data was exported from the instrument as a.Csv file (comma separated variables file) in an unusual format.Reportedly, the exported file did not properly separate individual data entries with commas into separate columns of the file and all data points were placed in the same column.The lab technician converted the original file into a tab delimited.Txt file (text file) using the third party application microsoft excel.The new file was sent to the forth party sunquest laboratory labaccess results workstation where erroneously calculated results were assigned to four separate patients.This resulted in patients being assigned results for the following tests that were inconsistent with results from the facscanto¿ 10 color configuration instrument generated reports.The following data was provided indicating the correct and erroneous values associated with the patient record: patient 3: incorrect cd3+ %826; correct %86.1, #5713.15.Incorrect cd3+/cd4+ %4448.8; correct %17.8, #1182.51.Incorrect cd3+/cd4+ #18; correct %1182.5, #1182.51.Incorrect cd3+/cd8+ %5713.2; correct %67, #4448.81.Incorrect cd4+: cd8+ ratio 6637.5; correct %1.8, #122.17.Incorrect cd16/56+ %122.2; correct %7.6, #505.97.Incorrect cd19+ %506.3; correct %5.6, #372.27.Incorrect cd45+ %99.3; correct %99.3, #6637.49.There was no indication that erroneous results led to a misdiagnosis or a deterioration of the patient¿s condition.

• Brand Name: FACSCANTO¿ 10 COLOR CONFIGURATION
• Type of Device: FLOW CYTOMETER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 8380444
• MDR Text Key: 137513422
• Report Number: 2916837-2019-00102
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382906573384
• UDI-Public: 00382906573384
• Combination Product (y/n): N
• PMA/PMN Number: K141468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 657338
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other