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

Model Number 98100

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer investigation to determine whether the device lot failed to meet specifications could not be pursued because the customer did not provide a lot number.Despite multiple attempts the customer did not provide the device lot number used.Based on the insufficient information, unable to determine any product deficiency.No corrective action is required.

Event Description

Field application specialist mentioned discrepant triage d-dimer result compared to reference lab.Triage d-dimer gave a result of 1900 while the lab gave a result of 100.Multiple attempts were made to obtain more information; customer did not provide any additional information.

• 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
• Manufacturer Contact: jessica perrotte ; 9975 summers ridge road; san diego, ca ; 3020297
• MDR Report Key: 10176957
• MDR Text Key: 201685339
• Report Number: 3013982035-2020-00021
• 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: 05/21/2020

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 Model Number: 98100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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