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

Model Number 97000HS

Device Problem Low Test Results (2458)

Patient Problem Myocardial Infarction (1969)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

The customer reported discrepant low tni results with triage cardiac results compared to another confirmatory method hstni for 1 patient.Customer stated that the patient symptoms were shortness of breath and chest pressue.Patient had a heart attack.Sample type for triage was edta whole blood.Customer did not provide any additional details.

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t13669n.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 t13669n 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 HS PANEL
• Type of Device: TRIAGE CARDIAC HS 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: 17356964
• MDR Text Key: 319684407
• Report Number: 3013982035-2023-00013
• 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: 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: 07/08/2023
• Device Model Number: 97000HS
• Device Lot Number: T13669N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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)
• Patient Age: 75 YR
• Patient Sex: Male