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

Model Number 98100EU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.Although this catalog number (98100eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 98100, 510(k) number k042890.

Event Description

Customer reported multiple discrepant results on the triage d-dimer panel with one patient.Customer stated they tested the patient on triage meterpro s/n (b)(4) and obtained results around 300-400ng/ml for d-dimer but on a second triage instrument (serial number not provided) obtained results around 800ng/ml.The patient sample was then sent to the laboratory and was confirmed to be around 800 ng/ml.Although requested, no additional information was provided by the customer.

Manufacturer Narrative

Investigation conclusion: customer returned the meter involved in the event ((b)(4)).The meters' memory history was reviewed in attempts to obtain the device lot number used during the customers reported discrepancy.A lot number was identified, triage d-dimer lot w63282rb.Customers complaint was not replicated with in-house testing of retain lot w63282rb with in-house triage meters and customers returned meter.No issues with d-dimer recovery were observed.Retain devices and customers returned meter performed properly.Manufacturing batch records for the lot were reviewed and found that the 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 (98100eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 98100, 510(k) number k042890.

• 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
• MDR Report Key: 7507654
• MDR Text Key: 108160841
• Report Number: 3013982035-2018-00012
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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 Expiration Date: 07/23/2018
• Device Model Number: 98100EU
• Device Lot Number: W63282RB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO (PN: (B)(4)): S/N (B)(4)