MAUDE Adverse Event Report: TRINITY BIOTECH, USA BARTELS ELISA LEGIONELLA URINIARY ANTIGEN; LEGIONELLA URINARY ANTIGEN

Model Number	B1029-440
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Laboratory user informed manufacturer that their new shipment of lua kits b1029-440 lot 056 was found to have some sort of gel/precipitate in every bottle of conjugate.
Event or Problem Description
Laboratory user informed manufacturer that their new shipment of lua kits b1029-440 lot 056 was found to have some sort of gel/precipitate in every bottle of conjugate.

• Brand Name: BARTELS ELISA LEGIONELLA URINIARY ANTIGEN
• Common Device Name: LEGIONELLA URINARY ANTIGEN
• 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: 12787010
• Report Number: 1318354-2021-00003
• Device Sequence Number: 5120487
• Product Code: MJH
• UDI-Device Identifier: 05391516744065
• UDI-Public: 05391516744065
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K991074
• 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: Recall,Replace
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 11/28/2022
• Device Model Number: B1029-440
• Device Catalogue Number: B1029-440
• Device Lot Number: 056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1318354-11/04/2021-002-R
• Patient Sequence Number: 1
• Patient Sex: Unknown