MAUDE Adverse Event Report: AB SCIEX CLIQUID MD SOFTWARE; LC/MS/MS SYSTEM

Model Number 5031225

Device Problem Computer Software Problem (1112)

Patient Problem No Information (3190)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Sciex's initial investigation suggests that the issue was caused by user error.When the customer tried to use the atraq on the 4500md lc/ms/ms, the customer appears to have used an incorrect isotope correction setting within the cliquid software, leading to miscalculation of results.There was no indication of patient injury or death.An investigation of the complaint is currently underway, and a follow up report will be submitted should additional information become available.Please be advised, as outlined by (b)(4) on 15 september 2017, sciex had submitted this emdr initial report (3008935545-2016-00001) on 30 november 2016 to the test webtrader account as a production webtrader account was not set up properly at this time.Now that a production webtrader account has been set up with the assistance of fda and esg we are formally submitting the same emdr initial report again to allow fda to process the submission further.As confirmed by (b)(4) on 15 september 2017: "you can make a note explaining that it was sent to test webtrader so your submission will not to be considered late." therefore based on the confirmation from (b)(4) and technical obstacles faced, this emdr initial report (3008935545-2016-00001) is not considered late.

Event Description

The customer from the (b)(6) indicated that they were experiencing reproducibility issues with their atraq kit on their 4500md lc/ms/ms system.Specifically, the customer believed the cliquid software, which is part of the 4500md lc/ms/ms, was miscalculating some results.

Manufacturer Narrative

It was initially reported that the customer appeared to use an incorrect isotope correction setting in cliquid software, leading to miscalculation of results.The results of the investigation determined that cliquid md software, when installed with no additional add-on components, is not designed to calculate results from amino acid analysis.If the amino acid feature within cliquid md isn't installed, then the software won't recognize amino acid data from the analysis acquisition and correct calculations will not occur.The only way to enable the amino acid feature in cliquid md is to active a unique software license.Once the amino acid license is active, there is no need to change the isotope correction factor when using atraq kits, since it's not required by the method.In this specific case, activation of the amino acid feature and modification to the isotopic correction factor were done at the same time, which lead to confusion regarding root cause of the miscalculation.Once the appropriate amino acid feature was installed for the customer, no further issues with incorrect calculations on amino acid analysis were reported.Please be advised, as outlined by fda via emdr@fda.Hhs.Gov on 15 september 2017, sciex had submitted this emdr follow-up report (3008935545-2016-00001s1) on 21 april 2017 to the test webtrader account as a production webtrader account was not set up properly at this time.Now that a production webtrader account has been set up with the assistance of fda and esg we are formally submitting the same emdr follow-up report (titled "3008935545-2016-00001s1" in test webtrader account but titled "3008935545-2016-00001s2" in production webtrader account) again to allow fda to process the submission further.As confirmed by fda via emdr@fda.Hhs.Gov on 15 september 2017: "you can make a note explaining that it was sent to test webtrader so your submission will not to be considered late." therefore based on the confirmation from fda and technical obstacles faced, this emdr follow-up report (3008935545-2016-00001s2) submitted via production webtrader is not considered late and completes the emdr submission for this case (3008935545-2016-00001s1 and 3008935545-2016-00001s2) as investigation has been completed.

Manufacturer Narrative

This follow-up report #2 (3008935545-2016-00001-s2) is being submitted to correct information/typo submitted within fields date of report and type of report of the initial report for 3008935545-2016-00001.This initial report was originally submitted via test webtrader on 30 november 2016 (to meet mdr reporting timelines requirements as a production webtrader was not set up yet) and then re-submitted via production webtrader on 19 september 2017 under report number 3008935545-2016-00001.Please refer to the production webtrader report 3008935545-2016-00001 for further details.This follow-up report #2 (3008935545-2016-00001-s2) is being submitted to correct information/typo submitted in the initial report for 3008935545-2016-00001 which was re-submitted to production webtrader on 19 september 2017.The initial report 3008935545-2016-00001 has a typo in fields date of report and type of report.For instance, date of report states "date of this report (dd-mmm-yyyy) as 30-oct-106" in the production webtrader 3008935545-2016-00001 initial report and in fact should be corrected to state the "date of this report (dd-mmm-yyyy) as 30-nov-2016"; to match the correct details as outlined in the initial report which was submitted to fda via test webtrader on 30 november 2016.Also, type of report states "type of report: as 30-day" in the production webtrader 3008935545-2016-00001 initial report and in fact should be corrected to state "type of report: as initial"; to match the correct details as outlined in the initial report which was submitted to fda via test webtrader on 30 november 2016.Please be advised, as outlined by fda via emdr@fda.Hhs.Gov on 15 september 2017, sciex (the manufacturer) had submitted this emdr initial report (3008935545-2016-00001) and follow-up #1 report (3008935545-2016-00001-s1) on 30 november 2016 and 21 april 2017, respectively, to the test webtrader account.Since a production webtrader account was not set up properly at that time for sciex.Now that a production webtrader account has been set up with the assistance of fda and esg, sciex is formally re-submitting the same emdr initial and follow-up #1 reports (titled "3008935545-2016-00001" and "3008935545-2016-00001s1," respectively, in production webtrader account) again to allow fda to process the submission further.As confirmed by fda via emdr@fda.Hhs.Gov on 15 september 2017: "you can make a note explaining that it was sent to test webtrader so your submission will not to be considered late." therefore based on the confirmation from fda and technical obstacles faced, all 3 emdr reports for this one case (initial report: 3008935545-2016-00001, follow-up #1 report: 3008935545-2016-00001-s1, and follow-up #2 report: 3008935545-2016-00001-s2) submitted via production webtrader are not considered late and completes the emdr submission for this case (3008935545-2016-00001) since investigation has been completed.

• Brand Name: CLIQUID MD SOFTWARE
• Type of Device: LC/MS/MS SYSTEM
• Manufacturer (Section D): AB SCIEX; 500 old connecticut path; framingham MA 01701
• Manufacturer (Section G): AB SCIEX; blk 33, #04-06; marsiling industrial estate; singapore, 73925 6; SN 739256
• Manufacturer Contact: nichole riek ; 500 old connecticut path; framingham, MA 01701 ; 5083837217
• MDR Report Key: 6877988
• MDR Text Key: 87755909
• Report Number: 3008935545-2016-00001
• Device Sequence Number: 1
• Product Code: DOP
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5031225
• Device Catalogue Number: 5032525
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other