MAUDE Adverse Event Report: ALERE SCARBOROUGH, INC. ID NOW INFLUENZA A & B2; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

The point of care test (poct) is to measure rapid flu testing and has false a and b positive results.It does not show an error code or show that the test could not be resulted if not run correctly.Instead it is providing a positive result.

Event Description

The point of care test (poct) is to measure rapid flu testing and has false a and b positive results.It does not show an error code or show that the test could not be resulted if not run correctly.Instead it is providing a positive result.

• Brand Name: ID NOW INFLUENZA A & B2
• Type of Device: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): ALERE SCARBOROUGH, INC.; 10 southgate rd; scarborough ME 04074
• MDR Report Key: 8288956
• MDR Text Key: 134789584
• Report Number: 8288956
• Device Sequence Number: 1
• Product Code: OCC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2019
• Event Location: Other
• Date Report to Manufacturer: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1