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

Model Number	97000HS
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing of retain device lot t10961n with normal "apparently healthy" donors.No issues with tni recovery observed; lot performed properly.Manufacturing batch records for the lot were reviewed, lot met release specifications.The root cause could not be determined.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) 2020, a male patient presented with light headedness, nausea and ringing ears.Patient was given zofran and fluids.Patient was tested on the triage platform four times.(time for tests was not provided).Ckmb: 3.5; myo: 147; tni: 0.17.Ckmb: 3.8; myo: 142; tni: <0.05.Ckmb: 4.1; myo: 144; tni: <0.05.Ckmb: 3.7; myo: 141; tni: <0.05.Although requested, no additional information provided.Facility triage cut-off for tni: 0.05.
Additional Manufacturer Narrative
Included test times in section b5.Customer provided patient final diagnosis which was also included in section b5.
Event or Problem Description
Customer reported the following occurring for one patient.On (b)(6) 2020, a male patient presented with light headedness, nausea and ringing ears.Patient was given zofran and fluids.Patient was tested on the triage platform four times.17:16: triage meter serial number (b)(6) : ckmb: 3.5; myo: 147; tni: 0.17.17:21: triage meter serial number (b)(6) : ckmb: 4.1; myo: 144; tni: <0.05.17:25: triage meter serial number (b)(6) : ckmb: 3.7; myo: 141; tni: <0.05.17:34: triage meter serial number (b)(6) : ckmb: 3.8; myo: 142; tni: <0.05.Facility triage cut-off for tni: 0.05.Patient was discharged on (b)(6) 2020 with no meds.Customer provided an update on 3/2/2020.Patient "final dx of myocarditis".

• Brand Name: TRIAGE CARDIAC PANEL
• Common Device Name: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego, ca
• MDR Report Key: 9772076
• Report Number: 3013982035-2020-00006
• Device Sequence Number: 16595005
• Product Code: MMI
• UDI-Device Identifier: 30014613337911
• UDI-Public: (01)30014613337911(10)T10961N(17)200527(11)190913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K030286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 05/27/2020
• Device Model Number: 97000HS
• Device Catalogue Number: 97000HS
• Device Lot Number: T10961N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIAGE METERPRO SN: (B)(6).
• Patient Age: 47 YR