MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC PANEL, TNI

Model Number	97021HS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting was performed with the customer.Technical support stressed the importance of testing patient samples within the 4-hour window for sample testing after collection per the product insert.Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64835rb.No issues with tni 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.
Event or Problem Description
Customer reported the following occurring for one patient.On (b)(6) 2019 a male patient presented to the ed with congestion.At 9:47 the patient was tested on triage and yielded a tni of 7.26.The doctor questioned the result because it was not consistent with patient presentation.New samples were drawn from the patient at 12:44 and 16:37; both draws resulted in triage tni <0.05.Customer repeated the 9:47 sample draw at 18:32 and received a result of <0.05 tni on triage.Customer stated that the patient was treated based on site's protocol for elevated tni when the 7.26 triage tni result was received.This included a second ekg, a chest x-ray, labs of cbc, cmp, ck, pt, and ptt.All tests were normal except for elevated glu, ast and alt and decreased co2.The ekg result was stated as sinus tachycardia.Customer listed heparin and plavix as the medications provided to the patient; it is unclear when these medications were administered to the patient.The patient was diagnosed with pneumonia.The customer stated the elevated triage tni result increased the patients' length of stay.

• Brand Name: TRIAGE CARDIAC PANEL, TNI
• Common Device Name: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8396911
• Report Number: 3013982035-2019-00004
• Device Sequence Number: 3026261
• Product Code: MMI
• UDI-Device Identifier: 00899722002788
• UDI-Public: (01)00899722002788(10)W64835RB(17)190519(11)180905
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K030286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2019
• Device Model Number: 97021HS
• Device Lot Number: W64835RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR