MAUDE Adverse Event Report: MESA BIOTECH ACCULA SARS COV-2 TEST; MOLECULAR SINGLE TARGET TEST FOR SARS COV-2

Model Number COV4100

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

Mesa continues to track, trend, capa assigned, and react to customer complaints.No adverse event occurred.The manufacturer has not confirmed that the device malfunctioned.Information reported by user is being reported as required by 21 cfr 803.

Event Description

Customer reported a false negative on a positive control swab.Information reported by user is being reported as required by 21 cfr 803.

• Brand Name: ACCULA SARS COV-2 TEST
• Type of Device: MOLECULAR SINGLE TARGET TEST FOR SARS COV-2
• Manufacturer (Section D): MESA BIOTECH; 6190 cornerstone ct; san diego CA 92121
• Manufacturer (Section G): MESA BIOTECH; 6190 cornerstone dt; suite 220; san diego CA 92121
• Manufacturer Contact: julie richardson ; 6190 cornerstone ct; suite 220; san diego, CA 92121 ; 6198614261
• MDR Report Key: 16454409
• MDR Text Key: 310371080
• Report Number: 3013022608-2023-00387
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA200028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: COV4100
• Device Lot Number: P22280-027
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1