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

Model Number 97021HS

Device Problem Low Test Results (2458)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t12759rn.Devices of the complaint lot performed properly when testing with a low level positive tni calibrator, no results <0.05ng/ml.Manufacturing batch records for lot t12759rn 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.

Event Description

Triage cardiac hs tni discrepant low when compared to siemens exl on 4 patient samples and 7 triage devices.The customer reported 3 critical results and 1 abnormal result per the siemens instrument that when tested on the triage meters indicated a result <0.05 ng/ml.Testing was performed for a tni comparison study.Unknown patient outcome, no treatment was given to the patient based on the triage results.Triage units are being implemented as back up only.No ae.

• 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: jessica perrotte ; 9975 summers ridge road; san diego, CA 92121 ; 8583020297
• MDR Report Key: 14163930
• MDR Text Key: 298962112
• Report Number: 3013982035-2022-00004
• 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: 04/20/2022

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: 07/21/2022
• Device Model Number: 97021HS
• Device Lot Number: T12759RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPROS PN: 55071, SN: (B)(4), SN: (B)(4).