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 Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retain device lot t10870rn.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.The lot performed properly.Manufacturing batch records for lot t10870rn 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 corrective action is required.Although this catalog number (98100eu) is not approved in the united states, the event is being reported as the device is same/similar to catalog number 98100 which is available us.

Event Description

Physician complained about triage d-dimer results not correlating to ultrasonic findings.Patient went to see doctor on may 18th for discomforts since may 13.Specifics around discomforts were not provided.Triage d-dimer resulted 314ng/ml.Physician cut-off for triage d-dimer: 0-400ng/ml patient diagnosed with "having a thrombosis of the vena axillaris and in vena subclavia after having switched to a different anti-contraceptive".Diagnosis confirmed by ultrasonic.Patient received medical stockings and medication xarelta.Physician stated there was no delay in treatment.

• 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: 10286404
• MDR Text Key: 202002495
• Report Number: 3013982035-2020-00026
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2020
• Device Model Number: 98100EU
• Device Lot Number: T10870RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2019
• 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