MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-19 for CLIQUID MD SOFTWARE 5031225 5032525 manufactured by Ab Sciex.
[87755909]
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.
Patient Sequence No: 1, Text Type: N, H10
[87755910]
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
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008935545-2016-00001 |
| MDR Report Key | 6877988 |
| Date Received | 2017-09-19 |
| Date of Report | 2017-09-20 |
| Date of Event | 2016-10-31 |
| Date Mfgr Received | 2016-10-31 |
| Date Added to Maude | 2017-09-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS NICHOLE RIEK |
| Manufacturer Street | 500 OLD CONNECTICUT PATH |
| Manufacturer City | FRAMINGHAM MA 01701 |
| Manufacturer Country | US |
| Manufacturer Postal | 01701 |
| Manufacturer Phone | 5083837217 |
| Manufacturer G1 | AB SCIEX |
| Manufacturer Street | BLK 33, #04-06 MARSILING INDUSTRIAL ESTATE |
| Manufacturer City | SINGAPORE, 739256 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 739256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLIQUID MD SOFTWARE |
| Generic Name | LC/MS/MS SYSTEM |
| Product Code | DOP |
| Date Received | 2017-09-19 |
| Model Number | 5031225 |
| Catalog Number | 5032525 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AB SCIEX |
| Manufacturer Address | 500 OLD CONNECTICUT PATH FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-19 |