MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-21 for CAPTIA? SYPHILIS (T. PALLIDUM) IGG 25029 manufactured by Trinity Biotech Usa.
[111980420]
Bio-rad technical support was contacted on (b)(6) 2018 by a bio-rad account manager on behalf of the customer at cerritos reference lab. The customer had a question as to how they should be reporting results for captia? (b)(6). The customer had switched from rpr testing to captia? (b)(6) igg testing during the third week of (b)(6) 2018, and the customer was reporting the captia? Syphilis (t. Pallidum) igg results out as rpr results. Bio-rad technical support informed the customer that they have been reporting out the results incorrectly, and provided the information as to how the results should be reported. As part of the incident investigation bio-rad technical support discovered that the customer was running captia? (b)(6) igg for tests that were ordered as rpr, and that the tests were reported as rpr. The customer reported that they have sent a letter out informing all of their clinics of the situation, and that the customer will take corrective action to resolve the incident. This incident is user error as the customer did not perform the test that was ordered by the physician, and the customer reported out results incorrectly. Because results were reported out incorrectly there is potential for harm to the patient due to delayed treatment or misdiagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2018-00003 |
| MDR Report Key | 7626067 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-05-10 |
| Date Added to Maude | 2018-06-21 |
| 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 | MR. DAVID BHEND |
| Manufacturer Street | 6565 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981758 |
| Manufacturer G1 | TRINITY BIOTECH USA |
| Manufacturer Street | 2823 GIRTS ROAD |
| Manufacturer City | JAMESTOWN NY 14701 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14701 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTIA? SYPHILIS (T. PALLIDUM) IGG |
| Generic Name | EIA |
| Product Code | LIP |
| Date Received | 2018-06-21 |
| Catalog Number | 25029 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRINITY BIOTECH USA |
| Manufacturer Address | 2823 GIRTS ROAD JAMESTOWN NY 14701 US 14701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-21 |