MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE D-DIMER PANEL

Model Number 98100

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customer reviewed their latest cap proficiency testing; performed in (b)(6) 2020.Results of that survey showed acceptable results when using triage d-dimer lot t11341n.The customer's complaint was not replicated during in-house testing of retain device lot t11341n.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.Lot performed within specification.Manufacturing batch records for lot t11341n 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 corrective action is required.

Event Description

Customer called stating that triage was reporting lower d-dimer results compared to (b)(6) lab immunoturbidometric test.On (b)(6) 2020, patient in their late 50's with symptoms of possible goat and right leg swelling was tested on triage and (b)(6).Triage d-dimer resulted 345ng/ml ddu.(b)(6) resulted = 0.87mcg/ml feu.Patient did not want any further scans done.Patient choosing to monitor symptoms.Customer stated, "so far no adverse outcomes." triage d-dimer: 400ng/ml ddu.(b)(6): 0.50mcg/ml feu.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: TRIAGE D-DIMER PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego, ca
• Manufacturer Contact: jessica perrotte ; 9975 summers ridge road; san diego, ca ; 3020297
• MDR Report Key: 10411217
• MDR Text Key: 204764169
• Report Number: 3013982035-2020-00028
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: 98100
• Device Lot Number: T11341N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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