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 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customers complaint was not replicated with in-house testing of retain lot t10455b.No issues with d-dimer recovery were observed.Manufacturing batch records for lot t10455b 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 reported correlation issues between triage d-dimer and stago analyzer during their evaluation phase of the triage d-dimer panel.Customer stated their site is not yet active with triage d-dimer.Triage d-dimer = 288 ng/ml ddu, stago = 630 ng/ml feu.Triage d-dimer = 221 ng/ml ddu, stago = 750ng/ml feu.The triage normal is < 400 ng/ml (0.4 ug/ml) and sanford lab's normal is < 0.5 ug/ml(500ng/ml).Customer performed their own conversion calculation on the stago results.Although requested, no patient diagnosis provided.No specific patient information provided.Customer stated that d-dimer for triage has not been implemented at their site since they are still in midst of attempting to validate the system for d-dimer, and therefore none of the results obtained on the triage have been reported out to physicians.Only the results on the stago would have been used in assessing/determining patient diagnosis/ treatment.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: TRIAGE D-DIMER
• 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: 9298707
• MDR Text Key: 204367610
• Report Number: 3013982035-2019-00030
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2019

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: 01/02/2020
• Device Model Number: 98100
• Device Lot Number: T10455B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• 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