MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR, INC. TRIAGE D-DIMER PANEL; FIBRIN SPLIT PRODUCTS

Model Number 98100

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: customers complaint was not replicated with in-house testing of retain lot w63227b.No issues with analyte recovery were observed and the product performed as expected.Manufacturing batch records for the lot were reviewed and found that the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer alleged a variance between the triage d-dimer panel and stago satelite analyzer.Results for one patient are as follows: triage d-dimer : 446ng/ml.Stago d-dimer : 0.67ug/ml.Cutoffs: triage=500 ng/ml ; stago=0.5 ug/ml.The triage d-dimer result was within customers normal range for d-dimer and stago result was abnormal.Customer stated patient was only treated on stago result.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: FIBRIN SPLIT PRODUCTS
• 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 ; 8588053573
• MDR Report Key: 7513159
• MDR Text Key: 108727085
• Report Number: 3013982035-2018-00013
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/14/2018

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: 05/21/2018
• Device Model Number: 98100
• Device Lot Number: W63227B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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