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

Model Number 98100

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 t11341n.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.Manufacturing batch records for lot t11341n 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.

Event Description

Customer reported the following for one patient.On (b)(6) 2020 patient presented to the hospital, symptoms unknown, and was tested for d-dimer on dsx, resulted 5,000 feu (cut-off >600).It is unknown what system dsx is, but confirmed it is not the triage system.Customer stated patient was "stable" enough to be discharged home with eliquis and lovenox and told to follow up with primary care doctor in 5 days.On (b)(6) 2020 patient returned to the facility and tested on the triage system which resulted in d-dimer <100ng/ml.Patient was diagnosed with community acquired pneumonia; caller could not tell how the diagnosis was reached.Patient went back to the facility on (b)(6) 2020 due to having shortness of breath, cough and gasping.When tested again on the dsx the patient resulted 4,428 feu.No additional information for this day.On (b)(6) 2020 patient presented back to facility.Triage d-dimer: 149ng/ml ddu (wb).Caller stated knowing about the previous results with this patient, they drew a nacitrate sample 1.5 hours later to be tested on the lab analyzer acl top 300.Lab analyzer resulted 1,794ng/ml feu (cut-off >500).Diagnosis for this day was not provided by the caller.Patient was not treated based on triage results.Patient is on elequis 5mg x2 a day and adderall.Patient was tested for covid multiple times and always negative, even with antibody test.Customer called back stating patient had ct scan on (b)(6) which showed no pe or dvt.Multiple attempts have been made to this customer to obtain more details around the event.

Manufacturer Narrative

Updated section b5 to include the additional information provided by the customer as well as patient diagnosis.

Event Description

Customer reported the following for one patient.On (b)(6) 2020 patient presented to the hospital, symptoms unknown, and was tested for d-dimer on dsx, resulted 5,000 feu (cutoff >600).It is unknown what system dsx is, but confirmed it is not the triage system.Customer stated patient was "stable" enough to be discharged home with eliquis and lovenox and told to follow up with primary care doctor in 5 days.On (b)(6) 2020 patient returned to the facility and tested on the triage system which resulted in d-dimer <100ng/ml.Patient was diagnosed with community acquired pneumonia; caller could not tell how the diagnosis was reached.Patient went back to the facility on (b)(6) 2020 due to having shortness of breath, cough and gasping.When tested again on the dsx the patient resulted 4,428 feu.No additional information for this day.On (b)(6) 2020 patient presented back to facility.Triage d-dimer: 149ng/ml ddu (wb).Caller stated knowing about the previous results with this patient, they drew a nacitrate sample 1.5 hours later to be tested on the lab analyzer acl top 300.Lab analyzer resulted 1,794ng/ml feu (cut-off >500).Diagnosis for this day was not provided by the caller.Patient was not treated based on triage results.Patient is on elequis 5mg x2 a day and adderall.Patient was tested for covid multiple times and always negative, even with antibody test.Customer called back stating patient had ct scan on (b)(6) which showed no pe or dvt.Multiple attempts have been made to this customer to obtain more details around the event.Additional information around this event was provided by the customer on july 2, 2020.Details below: "patient diagnosed on (b)(6) as dyspenea unspecified type, cough, history of acute respiratory failure, and community acquired pneumonia unspecified latterly." customer reported the patient did not clinically show any signs of dvt or pe (correlating with the triage result).Customer stated they are also doing an investigation into the dsx.

• 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
• MDR Report Key: 10204108
• MDR Text Key: 198680090
• Report Number: 3013982035-2020-00022
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: 98100
• Device Lot Number: T11341N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METER (PN:55040) SN: (B)(6)
• Patient Age: 32 YR