MAUDE Adverse Event Report: LUMINEX CORPORATION LUMINEX NEXTAG EXTENDED PANEL FOR COVID; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Inadequate Instructions for Healthcare Professional (1319)

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

Event Type  No Answer Provided  

Event Description

The nextag covid 19 extended panel package insert, assay package insert requires us to report the single gene positive as a positive result for covid-19.However, there is no consistency with this result.If you repeat it, this is causing issues because the single gene positive will most definitely come back as negative.With all the 3 genes, repeated tests will always come back as positive results.Fda should change the criteria for positive result.Only when all the 3 genes are positive the result should be positive otherwise negative.

• Brand Name: LUMINEX NEXTAG EXTENDED PANEL FOR COVID
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): LUMINEX CORPORATION
• MDR Report Key: 10698405
• MDR Text Key: 212387355
• Report Number: MW5097306
• 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: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1