MAUDE Adverse Event Report: MESA BIOTECH, INC. ACCULA SARS-COV-2 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number COV4100

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

Some of the accura supplied pipettes are shorter and they do not work with the test cartridges.This causes a delay in patient results, as well as a waste of the test cartridges.The length of the short sample possibly causes the error code "inadequate sample" on the dock.This is causing a delay in patient covid-19 testing results being obtained, which could delay treatment.This issue was recently identified at our other health system sites.We then checked and identified this pipette issue in 22 of our kits at the hospital with lot # and expiration date provided in this report.Note: the date above is of one of the instances from another site that triggered the review of the kits.We will provide additional lot # and site information in a follow-up message to this report.

• Brand Name: ACCULA SARS-COV-2 TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): MESA BIOTECH, INC.; 6190 cornerstone court e; suite 220; san diego CA 92121
• MDR Report Key: 11732360
• MDR Text Key: 247555490
• Report Number: 11732360
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: COV4100
• Device Catalogue Number: COV4100
• Device Lot Number: V2103F681K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2021
• Date Report to Manufacturer: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1095 DA
• Patient Weight: 17