MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE SOB PANEL

Model Number 97300EU

Device Problem Low Test Results (2458)

Patient Problem Myocardial Infarction (1969)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

Event cccurred in germany.On (b)(6) 2022, customer reported discrepant low triage sob troponin i results vs external lab troponin t results for 2 patients.Patient 1 was diagnosed with a nstemi as the first manifestation of a coronary 3-vessel disease.No patient diagnosis was provided for patient 2.Both patients were symptomatic.Patients were sent to hospital based on lab results.

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devces of lot number t12984n.Retains of the complaint lot were tested with a positive calibrator, no issues with tni recovery were observed.Lot performed within specification.Manufacturing batch records for lot t12984n 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 correction action is required.

• Brand Name: TRIAGE SOB PANEL
• Type of Device: TRIAGE SOB 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 ; 8583020294
• MDR Report Key: 15015724
• MDR Text Key: 295899911
• Report Number: 3013982035-2022-00010
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: 97300EU
• Device Lot Number: T12984N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2022
• 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: 55071
• Patient Sex: Male