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

Model Number	2326060
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: MEASLES IGM ELISA
• Manufacturer (Section D): TRINITY BIOTECH USA; 2823 girts road; jamestown NY 14701
• MDR Report Key: 11584644
• Report Number: 1318654-2021-00001
• Device Sequence Number: 11957257
• Product Code: PCL
• UDI-Device Identifier: 05391516743655
• UDI-Public: 05391516743655
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K140455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Notification
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: 2326060
• Device Catalogue Number: 2326060
• Device Lot Number: 060
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1318354-03/17/2021-001-R
• Patient Sequence Number: 1