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

Model Number 98100EU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w63286rb.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 (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

The customer reported discordant d-dimer results for one patient in the hospital.On (b)(6) 2018 the patient yielded a triage d-dimer of 1660 ng/ml, customer using a cut-off of 600 ng/ml.The patient sample was sent to another lab and tested for d-dimer using nyocard.D-dimer was 0.3 mg/l, customer using a cut-off of 0.3 mg/l.On (b)(6) 2018 the customer retested the patient sample on triage; d-dimer was 1720 ng/ml.Patient was diagnosed with vasovagal syncope.Patient was not diagnosed with deep vein thrombosis or pulmonary embolism.

• 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 ; 8588053573
• MDR Report Key: 7794810
• MDR Text Key: 117708070
• Report Number: 3013982035-2018-00023
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2018

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: 08/22/2018
• Device Model Number: 98100EU
• Device Lot Number: W63286RB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2018
• Initial Date FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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