FDA Adverse Event Malfunction Summary report: N

TRIAGE CARDIAC TRIPLE MARKER PANEL

MDR report key: 7525799 · Received May 18, 2018

Report

Report Number: 3013982035-2018-00014
Event Type: Malfunction
Date Received: May 18, 2018
Date of Event: April 20, 2018
Report Date: May 18, 2018
Manufacturer: QUIDEL CARDIOVASCULAR, INC.
Product Code: MMI
PMA / PMN Number: K030286
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EI
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION CONCLUSION: CUSTOMERS COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W63644RB. NO ISSUES WITH TNI RECOVERY WERE OBSERVED AND THE PRODUCT PERFORMED AS EXPECTED. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ALTHOUGH THIS CATALOG NUMBER (97000HSEU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 97000HS, 510(K) NUMBER K030286.

Description of Event or Problem · 1

CUSTOMER ALLEGED A DISCREPANCY WITH ONE PATIENT. PATIENT TESTED ON TRIAGE YIELDED A TNI OF 0.1, WHICH IS POSITIVE PER CUSTOMER. PATIENT SAMPLE WAS SENT TO THE LABORATORY FOR CONFIRMATION AND THE LAB YIELDED A TNI RESULT OF <0.05. SAMPLE WAS REPEATED ON THE TRIAGE SYSTEM IN THE MEDICAL UNIT AND THE RESULT WAS <0.05. CUSTOMER STATED THE TRIAGE DEVICES ARE LEFT IN DIRECT SUNLIGHT WHILE INCUBATING. CUSTOMER STATED THE ALLEGED DISCREPANCY MIGHT NOT HAVE BEEN A TRIAGE ISSUE AND THEY ARE INVESTIGATING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369222	TRIAGE CARDIAC TRIPLE MARKER PANEL	TRIAGE CARDIAC PANEL	MMI	QUIDEL CARDIOVASCULAR, INC.	97000HSEU	W63644RB

Patients

Seq	Age	Sex	Outcome	Treatment
1