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

Model Number	97000HS
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint was not replicated during in-house testing with retains of device lot w64049b.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
The customer reporting receiving conflicting triage tni results for a male patient.Triage tni results were as follows: (b)(6).Customer could not provide the reason for the patients visit to the ed, patients' medical history, patients' medication list or results from the ekg.Customer stated patient was not treated on triage results.Patients' outcome was no mi and patient was discharged.

• Brand Name: TRIAGE CARDIAC TRIPLE MARKER PANEL
• Common Device Name: TRIAGE CARDIAC TRIPLE MARKER PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7712391
• Report Number: 3013982035-2018-00021
• Device Sequence Number: 2771063
• Product Code: MMI
• UDI-Device Identifier: 00893038002197
• UDI-Public: (01)00893038002197(10)W64049B(17)181210(11)180326
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: 12/10/2018
• Device Model Number: 97000HS
• Device Lot Number: W64049B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR