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

Model Number 97000HS

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.Malfunction mdr for lot w63243b report number: 3013982035-2018-00004.

Event 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.

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
• Type of Device: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7250241
• MDR Text Key: 99316517
• Report Number: 3013982035-2018-00005
• Device Sequence Number: 1
• Product Code: JHX
• UDI-Device Identifier: 00893038002197
• UDI-Public: (01)00893038002197(10)W63316B(17)180429(11)170815
• 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: 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
• Device Operator: 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 Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1