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

Model Number 97000HS

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.Malfunction mdr for lot w63542b report number: 3013982035-2018-00015.

Event Description

Customer stated they performed a patient correlation from two site locations.One patient yielded a ckmb of 3.2ng/ml and myo of 96.3ng/ml on lot w63542b at sister site.The sample was transported at room temperature and ran at customers site on lot w63722b.Results were ckmb 5.3ng/ml and myo 140ng/ml.Customer could not provide additional information despite multiple attempts.A separate mdr will be filed for the results on lot w63542b.

Manufacturer Narrative

Investigation conclusion: customers complaint was not replicated with in-house testing of retain lot w63722b.No issues with recovery were observed and product performed properly.Manufacturing batch records for the lot were reviewed, the lot met release specifications.Customer was performing a patient correlation between two sites.Customer provided patient draw time and testing times when alleged discrepant results were received; more than 4 hours passed between patient draw time and last triage result.Per the product package insert, if using whole blood, the patient specimen should be tested within 4 hours of collection.Customer's results at their site were produced outside of this time-frame.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
• Type of Device: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7526133
• MDR Text Key: 108752928
• Report Number: 3013982035-2018-00016
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2018
• Device Model Number: 97000HS
• Device Lot Number: W63722B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO (PN:55070) SERIAL #(B)(4)