MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR, INC. TRIAGE PROFILER SOB PANEL

Model Number 97300EU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64169b.No issues with d-dimer recovery were observed, lot performed properly.Manufacturing batch records for the lot were reviewed, lot met 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 (97300eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.

Event Description

The customer reported discordant d-dimer results for one patient.Two samples were collected from the patient at the same time.Edta sample was ran on triage and serum sample was ran on acl top 550.Results are below: sample 1 : 477 ng/ml triage vs.741 ng/ml lab.Sample 2: 340 ng/ml triage vs.678 ng/ml lab.Although requested, patient outcome was not provided.Customer stated there was no delay in patient treatment and there was no patient harm.

• Brand Name: TRIAGE PROFILER SOB PANEL
• Type of Device: TRIAGE PROFILER SOB 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 ; 8588053573
• MDR Report Key: 7748824
• MDR Text Key: 116067520
• Report Number: 3013982035-2018-00022
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• Device Model Number: 97300EU
• Device Lot Number: W64169B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2018
• 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