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

Model Number	97300EU
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: KIT, TRIAGE, SOB
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7434896
• Report Number: 3013982035-2018-00008
• Device Sequence Number: 1544880
• Product Code: DAP
• UDI-Device Identifier: 00899722002740
• UDI-Public: (01)00899722002740(10)W63566B(17)180630(11)171016
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 97300EU
• Device Lot Number: W63566B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1