FDA Adverse Event Malfunction Summary report: N

ACCULA SARS COV-2 TEST

MDR report key: 11905700 · Received May 29, 2021

Report

Report Number: 3013022608-2020-00009
Event Type: Malfunction
Date Received: May 29, 2021
Date of Event: December 22, 2020
Report Date: January 22, 2021
Manufacturer: MESA BIOTECH
Product Code: QJR
PMA / PMN Number: EUA200028
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 505

Narratives

Additional Manufacturer Narrative · 1

CAPA IMPLEMENTED TO ENSURE HEATER ALIGNMENT OF THE CASSETTE TO PREVENT MELTING RISK ASSESSMENT ATTACHED - RISK DEEMED ACCEPTABLE ORIGINAL SUBMISSION FAILED ACKNOWLEDGEMENT 3 (ACK3) AND WAS NOT REALIZED UNTIL MAY 2021. MESA WORKED WITH THE ESG HELP DESK. THEIR RESPONSE AS FOLLOWS: THANK YOU FOR PROVIDING THE ACK3 FILE AND INVESTIGATING THE ISSUE WITH THE REPORTS. PLEASE NOTE, YOUR FIRM'S FEI NUMBER IS THE FIRST PART OF THE "MFR REPORT NUMBER" . WE CHECKED THE FDA ESTABLISHMENT REGISTRATION & DEVICE LISTING DATABASE AND IT SHOWS MESA BIOTECH INC. FEI NUMBER AS (B)(4). PLEASE RE-OPEN YOUR SUBMISSIONS IN ESUBMITTER, CORRECT THE REPORT NUMBERS USING YOUR FIRM'S REAL FEI NUMBER TO CORRECT THE ISSUE AND RESUBMIT THE FILES IN WEBTRADER.

Description of Event or Problem · 1

CUSTOMER CALLED IN ABOUT MELTING CASSETTES. NO ADVERSE EVENT OCCURRED. RISK ASSESSMENT PERFORMED. THE USED DEVICES WERE NOT RETURNED TO THE MANUFACTURER. THE MANUFACTURER HAS CONFIRMED THAT THE DEVICE MALFUNCTIONED. INFORMATION REPORTED BY USER IS BEING REPORTED AS REQUIRED BY 21 CFR 803.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
802045	ACCULA SARS COV-2 TEST	MOLECULAR SINGLE TARGET TEST FOR SARS COV-2	QJR	MESA BIOTECH	REF4100	20102108

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR