MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC TNI ONLY PANEL

Model Number 97021HS

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Event Description

The customer reported correlation issues with triage cardiac tni results compared to vitros 5600 tni for 1 patient.Customer has not established a cut-off for triage.Customer used serum on both triage cardiac and vitros 5600 on the 1st day and then serum on vitros 5600 and whole blood on triage cardiac the next day.Triage is a backup method.

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t13827rn.Devices of the complaint lot performed properly when testing with a positive calibrator, no issues with tni recovery were observed.Lot performed within specification.Manufacturing batch records for lot t13827rn were reviewed and found that the lot met final release specifications; however, the lot is associated with an ongoing recall related to the potential for negatively biased troponin results on triage cardiac panel.

• Brand Name: TRIAGE CARDIAC TNI ONLY PANEL
• Type of Device: TRIAGE CARDIAC TNI ONLY PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: chelsea lindgren ; 9975 summers ridge road; san diego, CA 92121 ; 8588055200
• MDR Report Key: 17358367
• MDR Text Key: 320064158
• Report Number: 3013982035-2023-00014
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/19/2023

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: 09/04/2023
• Device Model Number: 97021HS
• Device Lot Number: T13827RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO PN: 55070, SN: (B)(6).