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

Model Number 98100EU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

Customer's complaint was not replicated with in-house testing of retain lot w62880rb.No issues with analye recovery were observed and the product performed as expected.Manufacturing batch records were reviewed and found that the lot met release specifications.Based on the information available, there is no indicatoin of a product deficiency and no corrective action is required.

Event Description

The customer provided information regarding the following event occurring on one patient: patient a (all results on same patient same day and collection time, only difference is that pathcare does d-dimer on the green top tube heparinised blood) maxi medical lab triage d-dimer - 875ng/ml (reference range < 500ng/ml) pathcare d-dimer result - 0.42ug/ml (reference range < 0.5 ug/ml) customer did not know the methodology performed at pathcare site.There are no clinical details available for the patient.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: FIBRIN SPLIT PRODUCTS, PRODUCT CODE: GHH
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): 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: 7121925
• MDR Text Key: 95733642
• Report Number: 2024674-2017-00007
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: WA
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/15/2017

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: 11/27/2017
• Device Model Number: 98100EU
• Device Lot Number: W62880RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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