MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-08 for LIAISON TREPONEMA ASSAY 310480 manufactured by Diasorin S.p.a..
[3290884]
See user medwatch form, uf/importer report # (b)(4). Diasorin inc. Rec'd a complaint from (b)(6) 2012 regarding the diasorin liaison treponema assay, catalog number 310480. The liaison treponema assay uses chemiluminescent immunoassay (clia) technology on the liaison analyzer family for the qualitative determination of total antibodies directed against treponema pallidum in human serum. The presence of antibodies to treponema pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings may aid in the diagnosis of (b)(6) infection. The complaint alleged an increased number of reactive samples in the result upon resolution with rpr and tp-pa were negative. The lot number in question is 113025x/1 a sub lot of 113025x.
Patient Sequence No: 1, Text Type: D, B5
[10879032]
Conclusions: diasorin's investigation determined that the liaison treponema assay, catalog number 310480, lot number 113025x/1 meets assay performance requirements for negative agreement and expected false positives as stated within the ifu when using the reverse sequence syphilis screening algorithm according to the cdc mmwr from february 11, 2011 (discordant results from reverse sequence (b)(6) screening, five laboratories, united states, 2006-2010, mmwr (b)(4) 2011; (b)(4)). The product continues to perform consistent with its published performance specifications. Diasorin concludes that there has been no product malfunction nor death or serious injury which can be attributed to the use of the liaison treponema assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610240-2013-00001 |
| MDR Report Key | 3082583 |
| Report Source | 06 |
| Date Received | 2013-04-08 |
| Date of Report | 2013-04-08 |
| Date Mfgr Received | 2013-03-12 |
| Device Manufacturer Date | 2012-06-06 |
| Date Added to Maude | 2013-05-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | VIA CRESCENTINO |
| Manufacturer City | SALUGGIA (VC) 13040 |
| Manufacturer Country | IT |
| Manufacturer Postal | 13040 |
| Manufacturer Phone | 161487849 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIAISON TREPONEMA ASSAY |
| Product Code | LIP |
| Date Received | 2013-04-08 |
| Returned To Mfg | 2012-12-27 |
| Catalog Number | 310480 |
| Lot Number | 113025X |
| Device Expiration Date | 2013-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIASORIN S.P.A. |
| Manufacturer Address | SALUGGIA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-08 |