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

Model Number ABBOTT ID NOW

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 11/13/2020

Event Type  Injury  

Event Description

Patient tested positive for covid 19 on abbott id now, was hospitalized.Patient retested because physician questioned results.Sample recollected and tested on bd max system negative.Physicians are questioning abbott id now reliability in our facility.(5 false positives recorded.) fda safety report id # (b)(4).

• Brand Name: ABBOTT ID NOW
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 10851930
• MDR Text Key: 216886405
• Report Number: MW5097920
• 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
• Report Date: 11/13/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: ABBOTT ID NOW
• Device Lot Number: 1004831
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 21 YR