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 09/12/2023

Event Type  malfunction  

Event Description

The customer reported discrepant high d-dimer results for 1 patient tested 6 times in a day.No diagnosis or treatment provided.No ae.

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t14114n.Devices of the complaint lot performed properly when testing with normal edta whole blood from normal "apparently healthy" donors, no issues with d-dimer recovery were observed.Lot performed within specification.Manufacturing batch records for lot t14114n 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: chelsea lindgren ; 9975 summers ridge road; san diego, CA 92121 ; 8588055200
• MDR Report Key: 17926813
• MDR Text Key: 325585746
• Report Number: 3013982035-2023-00030
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: 98100
• Device Lot Number: T14114N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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
• Treatment: TRIAGE METERPRO PN: 55070, SN: (B)(6)