MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-12 for LIAISON TREPONEMA ASSAY manufactured by Diasorin S.p.a..
[3673790]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10947904]
A complaint of a discordant patient result was reported by the customer ((b)(6) hospital) on (b)(6) 2013 during a visit by the local diasorin application specialist. The status of liaison analyzer was investigated; records of preventive maintenance, service intervention and instrument checks performed prior to the date of the customer's initial test were reviewed and no anomalies were identified. The analysis of instrument log files suggest that there may have been the presence of bubbles or foam on the sample surface. Other potential causes may be: sample integrity issue or sample mishandling. The device history record for lot 113028x was reviewed and all samples characterized as equivocal or positive recovered as expected including a sample identified as std-3 (accepted range 1. 01 - 1. 68 index) with a result of 113028x dated (b)(6) 2013 utilizing (b)(4) samples from an open population were reviewed and all results were as expected, (b)(4) negative and (b)(4) positive. A natural low positive sample trep-(b)(4) also recovered as expected. A natural low positive sample trep-(b)(4) also recovered as expected. According to the cdc std treatments guidelines from 2010, "routine screening of newborn sera or umbilical cord blood is not recommended. Serologic testing of the mother's serum is preferred rather than testing of the infant's serum... " in conclusion diasorin's investigation determined that the liaison treponema assay, part number 310480, lot number 113028x meets all assay performance claims. This report does not reflect a conclusion by diasorin that this product caused or contributed to any alleged injury or illness or that is malfunctioned. This report is being submitted in compliance with the mdr regulations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610240-2013-00002 |
| MDR Report Key | 3234228 |
| Report Source | 06 |
| Date Received | 2013-07-12 |
| Date Mfgr Received | 2013-07-11 |
| Device Manufacturer Date | 2013-03-07 |
| Date Added to Maude | 2013-07-19 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | VIA CRESCENTINOM SNC |
| 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 | 2013-07-12 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |