MAUDE Adverse Event Report: CEPHEID CEPHIED COVID TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number 061034156192213

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Cepheid use for covid-19 under emergency use authorization (eua): attempted to perform covid test and when placing cartridge in machine the lid would not close to place in machine.Cartridge could not be used and new cartridge obtained to run test.Fda safety report id# (b)(4).

• Brand Name: CEPHIED COVID TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): CEPHEID
• MDR Report Key: 12129811
• MDR Text Key: 260451432
• Report Number: MW5102306
• Device Sequence Number: 1
• Product Code: QJR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 061034156192213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1