MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE D-DIMER 5 TEST

Model Number 98831EU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retain device lot t11827rn.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.The lot performed properly.Manufacturing batch records for lot t11827rn 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.Although this catalog number (98831eu) is not approved in the united states, the event is being reported as the device is same/similar to catalog number 98100 which is available us.

Event Description

A sales rep reported the following issue on behalf of a customer.Triage d-dimer reported a value of <100ng/ml (in the evening) on a patient who was suffering from painful red legs for two weeks.The next day patient underwent a radiography and the physician diagnosed a severe deep vein thrombosis.The patient received anticoagulant medication following radiography.

• Brand Name: TRIAGE D-DIMER 5 TEST
• 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: 11318622
• MDR Text Key: 232859009
• Report Number: 3013982035-2021-00002
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

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: 05/24/2021
• Device Model Number: 98831EU
• Device Lot Number: T11827RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1