MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-12 for LIAISON TREPONEMA ASSAY 310480 manufactured by Diasorin S.p.a..
[19725247]
A mother and neonate infant serum were collected and tested for treponema antibody using the diasorin liaison treponema assay (immunochemiluminescence). The mother was 23. 7 index (positive) and the infant was 0. 59 index (negative). Since the mother was positive, the customer decided to test the infant serum on rpr (rapid plasma reagin) and on fta-abs (fluorescent treponemal antibody) and both results were results were positive. The infant serum was then re-tested on a different liaison analyzer in duplicate and the results were 53. 2 and 52. 5 index (positive). Ref # 9610240-2013-00002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182595-2013-00001 |
| MDR Report Key | 3234219 |
| Date Received | 2013-07-12 |
| Date of Report | 2013-07-11 |
| Date of Event | 2013-06-15 |
| Date Facility Aware | 2013-06-17 |
| Report Date | 2013-07-11 |
| Date Reported to FDA | 2013-07-11 |
| Date Reported to Mfgr | 2013-07-11 |
| Date Added to Maude | 2013-07-19 |
| Event Key | 0 |
| Report Source Code | Distributor 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 |
| Manufacturer Street | 1951 NORTHWESTERN AVE. P.O. BOX 285 |
| Manufacturer City | STILLWATER MN 550820285 |
| Manufacturer Country | US |
| Manufacturer Postal | 550820285 |
| Manufacturer G1 | DIASORIN, INC. |
| Manufacturer Street | 1951 NORTHWESTERN AVE. P.O. BOX 285 |
| Manufacturer City | STILLWATER MN 55082028 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55082 0285 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIAISON TREPONEMA ASSAY |
| Product Code | LIP |
| Date Received | 2013-07-12 |
| Catalog Number | 310480 |
| Lot Number | 113028X |
| Device Expiration Date | 2014-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIASORIN S.P.A. |
| Manufacturer Address | SALUGGIA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-12 |