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

Model Number 97300EU

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63556b.No issues with tni recovery were observed.Manufacturing batch records for lot w63556b were reviewed and found that the lot met final release specifications.The customer could not provide patient diagnosis from the hospital specialized in cardiology.The only information available is patient is in good health condition.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

A patient experienced respiratory distress and was tested for cardiac markers using the triage system.The triage system produced results of tni= <0.05 ng/ml and bnp= 96 pg/ml.As the triage tni result was determined to be normal by the customer, the patient was taken to the emergency unit of a hospital instead of a hospital with a cardiology unit.The patient was tested in the emergency unit by another service an hour later and received results of tni= 0.0792 ng/ml and bnp= 387 pg/ml (normal tni cutoff for this instrument= 0.034 ng/ml).As this tni result was abnormal, the decision was made to transfer the patient to another hospital specialized in cardiology.The patient's diagnosis prior to transfer was heart failure and coronary distress.As of march 29, 2018, the patient is reported to be in good condition.

• Brand Name: TRIAGE PROFILER SOB PANEL
• Type of Device: KIT, TRIAGE, SOB
• 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: 7434896
• MDR Text Key: 105760339
• Report Number: 3013982035-2018-00008
• Device Sequence Number: 1
• Product Code: DAP
• UDI-Device Identifier: 00899722002740
• UDI-Public: (01)00899722002740(10)W63566B(17)180630(11)171016
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 97300EU
• Device Lot Number: W63566B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2017
• 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