MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT ID NOW COVID 19; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Virus (2136)

Event Date 05/29/2020

Event Type  malfunction  

Event Description

Abbott id now covid rapid test failed to detect covid 19 infection.Resulted in high risk exposure event to medical staff.

• Brand Name: ABBOTT ID NOW COVID 19
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 10114088
• MDR Text Key: 193947882
• Report Number: MW5094797
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Weight: 77