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

Model Number 97300EU

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customers complaint was not replicated with in-house testing of retains of lot t10556n.No issues with d-dimer recovery were observed.Manufacturing batch records for lot t10556n 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 (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

Customer reported elevated triage d-dimer results.On (b)(6) 2019, the lab received a whole blood patient sample from the doctor.Sample was tested on triage and yielded an elevated d-dimer of 2170ng/ml.The lab informed the doctor of the patients result.Patient was sent to the hospital on (b)(6) 2019.The hospital ran a d-dimer test and received an elevated d-dimer of 3.3.Method and units of the hospital test are unknown.The lab received an additional sample from the patient on (b)(6) 2019 and tested on triage again.Elevated d-dimer of 2070ng/ml was received.Patient had no deep vein thrombosis nor lung embolism.The patient has a lot of metastasis and final diangosis was cancer.Triage d-dimer cut-off: 400ng/ml.Hospital d-dimer cut-off: 0.5.

• Brand Name: TRIAGE PROFLER SOB PANEL
• Type of Device: TRIAGE PROFLER 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 ; 8583020297
• MDR Report Key: 9433342
• MDR Text Key: 219386903
• Report Number: 3013982035-2019-00033
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

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: 01/20/2020
• Device Model Number: 97300EU
• Device Lot Number: T10556N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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