MAUDE Adverse Event Report: TRINITY BIOTECH USA CAPTIA NMT SYPHILIS IGM KIT

Model Number 2329360

Device Problems Component Misassembled (4004); Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

This device is manufactured for export only and not sold in the us.The event occurred in (b)(6) and was reported as a field safety corrective action to hpra.

Event Description

A customer complaint was received stating that the labels for the positive and negative controls were on the wrong bottles.The customer provided photographs of the controls which confirmed the kit they had received did have the controls labelled incorrectly.The customer found the error prior to using the kit.

• Brand Name: CAPTIA NMT SYPHILIS IGM KIT
• Type of Device: CAPTIA NMT SYPHILIS IGM KIT
• Manufacturer (Section D): TRINITY BIOTECH USA; 2823 girts road; jamestown NY 14701
• Manufacturer Contact: pamela netzel ; 2823 girts road; jamestown, NY 14701 ; 7166910091
• MDR Report Key: 11841154
• MDR Text Key: 260732917
• Report Number: 1318654-2021-00002
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 05391516745048
• UDI-Public: 05391516745048
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Model Number: 2329360
• Device Catalogue Number: 2329360
• Device Lot Number: 125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other