FDA Adverse Event Malfunction Summary report: N

TRIAGE CARDIAC PANEL KIT

MDR report key: 7439653 · Received April 18, 2018

Report

Report Number: 3013982035-2018-00009
Event Type: Malfunction
Date Received: April 18, 2018
Date of Event: March 19, 2018
Report Date: April 18, 2018
Manufacturer: QUIDEL CARDIOVASCULAR, INC.
Product Code: JHX
PMA / PMN Number: K030286
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W63541RB. NO ISSUES WITH CKMB RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W63541RB 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. 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 THEIR LATEST BOX OF TRIAGE CARDIAC LOT W63451RB WAS GIVING ELEVATED RESULTS FOR CKMB WHILE MYO AND TNI WERE LESS THAN THE REFERENCE VALUE. THE CUSTOMER PROVIDED RESULTS OF 5.8NG/ML, 5.9NG/ML, 5.6NG/ML, 7.5NG/ML AND 4.5NG/ML FOR CKMB. THE CUSTOMER COULD ONLY PROVIDE DATA COMPARISON FOR THE RESULT OF 4.5NG/ML. THE SAMPLE WHEN TESTED ON AN ALTERNATE TRIAGE PRODUCT LOT NUMBER YIELDED A CKMB OF 3.8NG/ML. THE CUSTOMER STATED THEY DO NOT HAVE CONCERNS WITH THE ALTERNATE TRIAGE PRODUCT LOT. THE CUSTOMER STATED THE PATIENTS WERE NOT CORRELATED WITH A MI. NO ADDITIONAL INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
281886	TRIAGE CARDIAC PANEL KIT	TRIAGE CARDAIC PANEL	JHX	QUIDEL CARDIOVASCULAR, INC.	97000HSEU	W63541RB

Patients

Seq	Age	Sex	Outcome	Treatment
1