• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

QUIDEL CARDIOVASCULAR INC. TRIAGE D-DIMER 5 TEST Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11318622
MDR Text Key232859009
Report Number3013982035-2021-00002
Device Sequence Number1
Product Code GHH
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K042890
Number of Events Reported1
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 Date05/24/2021
Device Model Number98831EU
Device Lot NumberT11827RN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/14/2021
Initial Date FDA Received02/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-