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

Model Number 97300EU

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64210rb.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 (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 called in stating they received a late delivery of triage sob devices.The product was in transit for four days.The customer was not informed of the delay in delivery until after testing was performed on a patient.Details of the patient testing are as follows: patient presented with right thorax pain (previously inpatient in urology).The patient was tested on triage and yielded a d-dimer of 1430ng/ml.In addition to the elevated d-dimer result, infection parameters were also increased with the patient (crp, leukos, and bsg).Patient was started on antibiotic therapy.A ct of the thorax and pulmonary scintigraphy was ordered for the patient.No left atrium enlargement (lae) identified.The doctor felt the increased d-dimer was due to the inflammation.

• Brand Name: TRIAGE PROFILER SOB PANEL
• Type of Device: TRIAGE PROFILER 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 ; 8588053573
• MDR Report Key: 7820858
• MDR Text Key: 118406120
• Report Number: 3013982035-2018-00024
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Model Number: 97300EU
• Device Lot Number: W64210B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR