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

Model Number 97021HS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint of discrepant results with tni was not replicated with in-house retain testing of triage cardiac lot t14376rn with an in-house calibrator.No issues with tni recovery were observed.Manufacturing batch records for the lot were reviewed and found that the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

Correlation issues with tni on cardiac vs hs-tni on siemens exl; correlating results over multiple patients.Symptoms: sample 1: a-fib, rapid ventricular heartbeat; sample 4: mi symptoms.Diagnoses: sample 1: acute mi, chf, sepsis; sample 4: not provided.

• 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 CA 92121
• Manufacturer Contact: francis castro ; 9975 summers ridge road; san diego, CA 92126 ; 8583020818
• MDR Report Key: 18961673
• MDR Text Key: 338612185
• Report Number: 3013982035-2024-00006
• 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
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97021HS
• Device Lot Number: T14376RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2023
• 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: 81330.