MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-01-03 for DSX 65100 manufactured by Dynex Technologies Inc.
[63769847]
Patient Sequence No: 1, Text Type: N, H10
[63769848]
Dynex technologies inc - manufacturer of the dsx "open" automated immunoassay instrument. (b)(4) - distributor of immunoassay equipment and assays. Trinity biotech ((b)(4)) - manufacturer of trep-sure anti-treponema assay ((b)(6)). On december 4th 2016 (b)(6) reported to dynex technologies inc. That a (b)(6) using the trinity biotech ((b)(4)) trep-sure microplate assay on the dynex dsx analyzer had led to a patient receiving a liver biopsy for (b)(6). The biopsy was (b)(6). A retest of the (b)(6) was run and the new patient sample was found to be (b)(6). The patient has since been diagnosed with (b)(6). (b)(6) hospital, on review of the data, discovered erratic results which they claim may be caused by the dsx analyzer, serial number (b)(4). Dynex commenced an investigation and found the following: the instrument's pipette module had been replaced on 6th december by dynex field service at alere's request (the company who placed the instrument and trained the users at (b)(6) hospital). The pipette module was sent back to dynex technologies. The pipette module was tested extensively and found to be in specification. Dynex has found that the dsx automated pipetting system at (b)(6) is being operated with consumables that are outside permissible limits relative to the configuration settings. Further, an unsupported practise of inserting undefined sample tubes in order to accommodate low sample volumes is routinely employed. Both practises provide the potential for erroneous results related to the pipetting of samples and reagents. Dynex has concluded that the dsx system is not malfunctioning but has identified processes in the laboratory that might potentially lead to erroneous results
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1117676-2016-00003 |
| MDR Report Key | 6219731 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-03 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-12-04 |
| Device Manufacturer Date | 2011-10-21 |
| Date Added to Maude | 2017-01-03 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CANDICE PROWSE |
| Manufacturer Street | 14340 SULLYFIELD CIRCLE |
| Manufacturer City | CHANTILLY VA 201511621 |
| Manufacturer Country | US |
| Manufacturer Postal | 201511621 |
| Manufacturer Phone | 5714550811 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DSX |
| Generic Name | AUTOMATED ELISA SYSTEM |
| Product Code | JQW |
| Date Received | 2017-01-03 |
| Model Number | DSX |
| Catalog Number | 65100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNEX TECHNOLOGIES INC |
| Manufacturer Address | 14340 SULLYFIELD CIRCLE CHANTILLY VA 201511621 US 201511621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-03 |