MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-19 for QUANTA FLASH H-TTG IGA manufactured by Inova Diagnostics, Inc.
[75855402]
Several complaints have been received by the laboratory where the inova quanta flash human tissue transglutaminase iga testing did not fit the clinical picture or there were negative results by other reference laboratories. Dates of use: (b)(6) 2017. Diagnosis or reason for use: aid in the diagnosis of the gluten sensitive enteropathies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069924 |
| MDR Report Key | 6584659 |
| Date Received | 2017-05-19 |
| Date of Report | 2017-05-19 |
| Date of Event | 2017-04-17 |
| Date Added to Maude | 2017-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUANTA FLASH H-TTG IGA |
| Generic Name | AUTOANTIBODIES, ENDOMYSIAL (TISSUE TRANSGLUTAMINASE |
| Product Code | MVM |
| Date Received | 2017-05-19 |
| Lot Number | 1059 |
| Device Expiration Date | 2017-11-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INOVA DIAGNOSTICS, INC |
| Brand Name | QUANTA FLASH H-TTG IGA |
| Generic Name | AUTOANTIBIOTICS, ENDOMYSIAL (TISSUE TRANSGLUTAMINASE) |
| Product Code | MVM |
| Date Received | 2017-05-19 |
| Lot Number | 1292 |
| Device Expiration Date | 2018-02-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INOVA DIAGNOSTICS, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-19 |