MAUDE Adverse Event Report: TRINITY BIOTECH USA CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG; EIA

Catalog Number 25029

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  Injury  

Event Description

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.

• Brand Name: CAPTIA¿ SYPHILIS (T. PALLIDUM) IGG
• Type of Device: EIA
• Manufacturer (Section D): TRINITY BIOTECH USA; 2823 girts road; jamestown NY 14701
• Manufacturer (Section G): TRINITY BIOTECH USA; 2823 girts road; jamestown NY 14701
• Manufacturer Contact: david bhend ; 6565 185th ave ne; redmond, WA 98052 ; 4254981758
• MDR Report Key: 7626067
• MDR Text Key: 111980420
• Report Number: 3022521-2018-00003
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 05391516744829
• UDI-Public: 05391516744829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 25029
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other