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

Model Number 97021HS

Device Problem Low Test Results (2458)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devces of lot number t13459rn.Retains of the complaint lot performed properly when tested with "normal" (apparently healthy) donors.Manufacturing batch records for lot t13459rn were reviewed and found that the lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

Event occurred in the united states of america.On (b)(6) 2022 the customer tested a patient due to abdominal pain.Patient result was 0.05 ng/ml which is a borderline cutoff result.The patient then went to the hospital and the electrocardiogram showed atrial fibrillation.No confirmatory tni testing was done that day at the hospital.Three days later the patient was tested and the high sensitivity result was normal, 47ng/l (4.7ng/ml).There was no testing done between the first triage result and the testing three days later.Patient was then diagnosed with a congestive heart failure and the discharge instructions were to follow up with a cariologist.One month later the patient had a heart transplant.

• Brand Name: TRIAGE CARDIAC HS TNI PANEL
• Type of Device: TRIAGE CARDIAC HS TNI PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego 92121
• Manufacturer Contact: chelsea lindgren ; 9975 summers ridge road; san diego, CA 92121 ; 8583020294
• MDR Report Key: 17353606
• MDR Text Key: 319349193
• Report Number: 3013982035-2023-00012
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• 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: 04/25/2023
• Device Model Number: 97021HS
• Device Lot Number: T13459RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2022
• 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)