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

Model Number 98100

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

Customer reported discordant d-dimer results from 3 patients between the triage d-dimer panel and the acl top.Customer would only provide the following information.Triage d-dimer result = 326ng/ml ddu and acl top d-dimer result 445ng/ml.Site reference ranges: acl top 0 -500 ng/ml.Triage d-dimer: less than 100 - 240, established in (b)(6) 2020.

Manufacturer Narrative

Investigation conclusion: the customers complaint was not replicated during in-house testing of retain device lot t12494n.The lot performed properly when tested with "normal" (apparently healthy) donors.Manufacturing batch records for lot t12494n 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 correction action is required.

• 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: 13114933
• MDR Text Key: 290562855
• Report Number: 3013982035-2021-00018
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2022
• Device Model Number: 98100
• Device Lot Number: T12494N
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO (PN:55070) SN: 84423