MAUDE Adverse Event Report: TRINITY BIOTECH USA CAPTIA MEASLES IGM ELISA KIT

Model Number 2326060

Device Problem Unable to Obtain Readings (1516)

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

Event Date 02/10/2021

Event Type  malfunction  

Event Description

Laboratory user informed manufacturer that captia measles igm kit was reporting invalid assays on two kits from lot 060 due to positive control values being above the assigned isr range.No injury was reported.

• Brand Name: CAPTIA MEASLES IGM ELISA KIT
• Type of Device: MEASLES IGM ELISA
• 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: 11584644
• MDR Text Key: 243910392
• Report Number: 1318654-2021-00001
• Device Sequence Number: 1
• Product Code: PCL
• UDI-Device Identifier: 05391516743655
• UDI-Public: 05391516743655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 2326060
• Device Catalogue Number: 2326060
• Device Lot Number: 060
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1318354-03/17/2021-001-R
• Patient Sequence Number: 1