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

Model Number 97000HS

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.

Event Description

The customer reported discordant ck-mb results for a patient presenting with chest pain and shortness of breath.Patients whole blood sample was tested on triage cardiac lot w63734b, results were: ck-mb=7.5ng/ml, myo=168ng/ml, tni=<0.05ng/ml.Patient was sent to hospital.Patient was re-drawn at the hospital 3 hours after the triage result on the roche cobas, ck-mb = 2.9ng/ml triage ck-mb cut-off: 4.3ng/ml.Customer did not know the roche cobas cut-off.Customer did not know patient diagnosis but stated the patient was sent home.Customer confirmed patient was not treated on triage result.

Manufacturer Narrative

Customer returned their triage meterpro (sn: (b)(4).In-house testing of customers returned meter alongside in-house triage meters showed the returned meter is performing properly.No issues observed with customers returned meter.Customers complaint was not replicated with in-house testing of retain lot w63734b with normal donor population.All results were as expected and product performed properly.Manufacturing batch records for the lot were reviewed, the lot met 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 TRIPLE MARKER PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7708984
• MDR Text Key: 114684848
• Report Number: 3013982035-2018-00019
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2018
• Device Model Number: 97000HS
• Device Lot Number: W63734B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO (PN:55070) SERIAL #: (B)(4)
• Patient Age: 72 YR