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

Model Number 98100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customers complaint was not replicated with in-house testing of retain lot w64945b.No issues with d-dimer recovery were observed.Manufacturing batch records for lot w64945b 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.Malfunction mdr for lot w64947b report number: 3013982035-2018-00019.

Event Description

Customer reported conflicting d-dimer results on the triage platform.Patient whole blood was tested on triage d-dimer lot w64945b; which resulted in a d-dimer of 290.Patient sample was spun down to plasma and frozen.Frozen sample was tested the next day at customers sister site on triage d-dimer lot w64947b; which resulted in a d-dimer of 452.Customer told physician to disregard the d-dimer results since they did not correlate.Sites cut-off for d-dimer is 400.Patient was contacted and told to get another d-dimer test.Contact could not confirm if any treatment had been performed based on triage results.No additional information available.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: TRIAGE D-DIMER PANEL
• 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: 8893379
• MDR Text Key: 216681906
• Report Number: 3013982035-2019-00018
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 98100
• Device Lot Number: W64945B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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