FDA Adverse Event Malfunction Summary report: N

TRIAGE TOX DRUG SCREEN PANEL

MDR report key: 9158222 · Received October 4, 2019

Report

Report Number: 3013982035-2019-00024
Event Type: Malfunction
Date Received: October 4, 2019
Date of Event: September 2, 2019
Report Date: October 4, 2019
Manufacturer: QUIDEL CARDIOVASCULAR INC.
Product Code: DIO
PMA / PMN Number: K060791
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF FALSE NEGATIVE COC AND OPI WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAINS OF LOT T10079RN. MANUFACTURING BATCH RECORDS FOR LOT T10079RN 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 (94400EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 94400, 510(K) NUMBER K060791.

Description of Event or Problem · 1

THE CUSTOMER REPORTED FALSE NEGATIVE TRIAGE COCAINE AND OPIATE RESULTS ON A PATIENT TAKING COCAINE AND HEROIN. PATIENT SAMPLE WAS TESTED ON TRIAGE WHICH YIELDED NEGATIVE RESULTS FOR ALL DRUG ANALYTES. THE SAMPLE WAS TESTED ON NARCOCHECK TEST CARD AND GAVE POSITIVE RESULTS FOR COC, MOR AND EDDP. SAMPLE WAS ALSO TESTED ON SURESTEP TEST CARD AND GAVE POSITIVE RESULTS FOR COC AND MOP. CUSTOMER STATED SAMPLE WAS ALSO SENT TO THE LAB FOR ANALYSIS ON DIMENSION VISTA BUT THOSE RESULTS WERE NOT PROVIDED. NO CONFIRMATORY TESTED WAS PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
953071	TRIAGE TOX DRUG SCREEN PANEL	TRIAGE TOX DRUG SCREEN	DIO	QUIDEL CARDIOVASCULAR INC.	94400EU	T10079RN

Patients

Seq	Age	Sex	Outcome	Treatment
1