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 08/12/2023

Event Type  malfunction  

Event Description

Event occurred in india.Conflicting results on 1 patient.Triage sob vs lab hstni: patient 1: on (b)(6) 2023:sob tni <0.05 ng/ml.On (b)(6) 2023: hstni 116.88 pg/ml.No symptoms provided.Diagnosis: nstemi.Triage sob it is abnormal only above 0.40ng/ml.Hstni elevated risk >12 pg/ml.

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated with in-house retain testing of triage tni t14104n with an in-house calibrator.No issues with tni recovery were observed, the lot performed as expected.Reviewed the batch record for triage tni lot t14104n.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.This trend will be continuously monitored through incoming complaints.

• 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: 17751213
• MDR Text Key: 324082111
• Report Number: 3013982035-2023-00027
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/14/2023

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: 01/10/2024
• Device Model Number: 97300EU
• Device Lot Number: T14104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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: 55070, SN: (B)(6).