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

Model Number 97300EUA

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64982n.No issues with d-dimer recovery were observed, lot performed properly.Manufacturing batch records for the lot were reviewed, lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Although this catalog number (97300eua) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 98100, 510(k) number k042890.

Event Description

Event occurred in (b)(6).Customer reported discrepant low d-dimer results for 1 patient.Patient 2: normal triage d-dimer = 107 ng/ml.Ultrasound confirmed deep vein thrombosis.Customer's triage d-dimer cutoff- 400 ng/ml.Customer stated no treatment was withheld based on triage result.

• Brand Name: TRIAGE PROFILER SOB PANEL
• Type of Device: TRIAGE PROFILER SOB 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: 8588876
• MDR Text Key: 146361865
• Report Number: 3013982035-2019-00010
• Device Sequence Number: 1
• Product Code: DAP
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2019
• Device Model Number: 97300EUA
• Device Lot Number: W64982N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2018
• 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