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

Model Number	97022HS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint was not replicated during in-house testing with retains of device lot w64617rb.No issues with troponini 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
On (b)(6) 2018 a patient presented to the customers' facility with shortness of breath (no other symptoms noted).Facility ran the triage panel on the patient.  tni=0.48ng/ml, ckmb= less than 1.0ng/ml.Site's critical cutoff for tni is greater than 0.50ng/ml, however the result of 0.48ng/ml was considered abnormal.  patient was then sent to the er for further evaluation.(to customer's knowledge no further action or treatment was taken based off of the triage result).  er tested tni on their beckman system, tni = less than 0.03.A total of 3 draws were obtained (4 hours apart) and all resulted less than 0.03ng/ml on beckman for the patient.Customer stated the er communicated their tni result(s) to them and so the facility reran the patient sample on the triage panel with a new test device, same draw ( at room temperature past 4 hours from collection).Repeat tni= less than 0.05ng/ml.   patient was discharged on (b)(6) 2018.No further information available on diagnosis, it is unknown if an ekg was performed at the emergency room.

• Brand Name: TRIAGE CARDIAC PANEL, TNI/CKMB
• Common Device Name: TRIAGE CARDIAC PANEL, TNI/CKMB
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8098926
• Report Number: 3013982035-2018-00031
• Device Sequence Number: 1721794
• Product Code: MMI
• UDI-Device Identifier: 00899722002795
• UDI-Public: (01)00899722002795(10)W64617RB(17)190225(11)180611
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/22/2018

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: 02/25/2019
• Device Model Number: 97022HS
• Device Lot Number: W64617RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 93