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

Model Number COV4100

Device Problem Nonstandard Device (1420)

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Capa to ensure heater alignment of the cassette and investigate other actions to prevent melting.

Event Description

Customer reports experiencing smoking dock.No adverse event occurred.The used devices were not returned to the manufacturer.The manufacturer has confirmed that the device most likely malfunctioned based on complaint information provided.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: 16009905
• MDR Text Key: 305803385
• Report Number: 3013022608-2022-00356
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: COV4100
• Device Lot Number: P21134-002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• 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