FDA Adverse Event Malfunction Summary report: N

TRIAGE CARDIAC HS PANEL

MDR report key: 9216468 · Received October 21, 2019

Report

Report Number: 3013982035-2019-00026
Event Type: Malfunction
Date Received: October 21, 2019
Date of Event: September 6, 2019
Report Date: September 23, 2019
Manufacturer: QUIDEL CARDIOVASCULAR INC.
Product Code: MMI
PMA / PMN Number: K030286
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT T10431RN. NO ISSUES WITH TNI RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT T10431RN 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 REPORTED DISCORDANT RESULTS BETWEEN TRIAGE AND SIEMENS DIMENSION EXL ANALYZER. PATIENT SAMPLE DRAWN AT 9AM ON (B)(6) 2019. TESTING ON TRIAGE PANEL RESULTED IN THE FOLLOWING: CKMB 19.7 NG/ML (ABOVE CUT-OFF OF 4.3 NG/ML). MYO 178 NG/ML (ABOVE CUT-OFF OF 107 NG/ML). TROP I 0.15 NG/ML (BELOW CUT-OFF OF 0.40 NG/ML). A DIFFERENT SAMPLE DRAWN AT THE SAME TIME AS TRIAGE, RESULTED ON THE EXL ANALYZER: 0.610 NG/ML (ABOVE CUT-OFF OF 0.10 NG/ML). CUSTOMER STATED THE PATIENT HAD A HEART ATTACK AND CONFIRMED THERE WAS NO DELAY IN TREATMENT DUE TO THE TRIAGE RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1007640	TRIAGE CARDIAC HS PANEL	TRIAGE CARDIAC PANEL	MMI	QUIDEL CARDIOVASCULAR INC.	97000HSEU	T10431RN

Patients

Seq	Age	Sex	Outcome	Treatment
1