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

Model Number 97300EU

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)

Patient Problem Myocardial Infarction (1969)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated with in-house retain testing of triage sob t14491n with an in-house calibrator.No issues with tni recovery were observed, the lot performed as expected.Reviewed the batch record for triage sob lot t14491n.The lot met all final release specifications.No issues with tni recovery were observed.Based on the information available, there is no indication of a product deficiency and no corrective action is required.The case details were reviewed along with the complaint history of this product for the reported failure mode; no issues were identified.Based on the information available, there is no indication of a product deficiency an no corrective action is required.

Event Description

Event occurred in germany.Discrepant results on patient 1: occurred on 1/30/2024 patient 1: 79 year old male.Triage sob troponin i vs lab tnt (high sensitivity troponin t on either cobas pure or cobas pro) patient was symptomatic.Final diagnosis: acute coronary syndrome with stenting.Patient also got nstemi.

• 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: 18778650
• MDR Text Key: 336314174
• Report Number: 3013982035-2024-00001
• Device Sequence Number: 1
• Product Code: MMI
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97300EU
• Device Lot Number: T14491N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2023
• 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: 55071, SN: (B)(6)
• Patient Age: 79 YR
• Patient Sex: Male