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

Model Number 97000HS

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64043b.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 Description

The customer provided the following data for a correlation study using patient samples between the triage system and ortho eci analyzer.On (b)(6) 2018: (b)(6).Ortho eci cutoff is >0.06.Triage cutoff is >0.05.Customer stated no treatment or medical decisions were made from the results obtained on the triage meter, they were solely used for the 6 month correlation testing since the triage meter is used as a backup method only.No additional information provided.

• Brand Name: TRIAGE CARDIAC TRIPLE MARKER PANEL
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: jessica perrotte ; 9975 summers ridge road; san diego, CA 92121 ; 8588053573
• MDR Report Key: 7680497
• MDR Text Key: 113888107
• Report Number: 3013982035-2018-00018
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2018
• Device Model Number: 97000HS
• Device Lot Number: W64043B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1