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

Model Number	97000HS
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.Malfunction mdr for lot w63243b report number: 3013982035-2018-00004.
Event or Problem Description
The customer reported observing a variance for myoglobin during a lot to lot comparison with two different triage cardiac lot numbers.Patient results: triage cardiac lot w63243b, myo=90.1, triage cardiac lot w63316b, myo=118.Myoglobin reference range: 0-106 ng/ml.Patient was not treated based on the triage results.
Additional Manufacturer Narrative
Investigation conclusion: the customers complaint was not replicated with in-house testing of retain lot w63316b.No issues with myo recovery observed.Manufacturing batch records for lot w63316b were reviewed and found that the lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: TRIAGE CARDIAC TRIPLE MARKER PANEL
• Common Device Name: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7250241
• Report Number: 3013982035-2018-00005
• Device Sequence Number: 19091560
• Product Code: JHX
• UDI-Device Identifier: 00893038002197
• UDI-Public: (01)00893038002197(10)W63316B(17)180429(11)170815
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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: 04/29/2018
• Device Model Number: 97000HS
• Device Lot Number: W63316B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1