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

Model Number 98100

Device Problem High Readings (2459)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot t10094n.No issues with d-dimer recovery were observed, lot performed properly.Manufacturing batch records for the lot were reviewed, 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 reported slightly elevated d-dimer results for one patient.Patient 1 on (b)(6) 2019- 1100ng/ml result data- female patient, chest x-ray done, no pe, cta chest pe with contrast done, negative for pe.An ascending thoracic aortic aneurysm discovered, surgical consult suggested.Atherosclerotic calcification seen, heart enlarged.No hemolysis of sample.Cta chest pe with contrast is mentioned in outcomes to adverse event.Reference range 0-600ng/ml.No critical value.No treatment administered/withheld based on the triage results.

Event Description

Customer reported observing elevated d-dimer results on the triage system for a patient.Patient was tested on triage and yielded a positive d-dimer result of 1100ng/ml.Sites' reference range is 0-600ng/ml.Customer stated no other coagulation tests were conducted.Customer stated patient had a chest x-ray done, no pe identified.Patient also had a "cta chest pe with contrast done, negative for pe".Patient was found to have an ascending thoracic aortic aneurysm and "atherosclerotic calcification seen, heart enlarged".

Manufacturer Narrative

Corrected: included patient gender in section a3.Dates listed in section b3, b5, b6 and d11 were incorrect in the initial mdr report.Updated patient code in h6.

• 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 92121
• MDR Report Key: 8805651
• MDR Text Key: 151564985
• Report Number: 3013982035-2019-00017
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2019
• Device Model Number: 98100
• Device Lot Number: T10094N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO PN: 55070 LOT NUMBER: 76877; TRIAGE METERPRO PN: 55070, SERIAL NUMBER: (B)(6).
• Patient Outcome(s): Other