MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH INC. ID NOW COVID-19 ASSAY; MOLECULAR IVD FOR ID NOW COVID-19

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The required intake information to enable further investigation, such as the kit's lot number and logfiles, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaint's trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics was unable to determine the exact root cause of the reported issues as no information was provided for investigation or vigilance reporting.

Event Description

The false positive/conflicting results were reported with the abbott rapid antigen test.However, that test was not available at the time of the report.Therefore, we will consider the report to be for id now covid-19 assay.Fda medwatch (report #: mw5096091) reported a false positive/conflicting result with testing of idnow covid-19 test assay using nasal swabs performed on (b)(6) 2020.A second test generated negative results, but no additional information about that test was provided (ct results not provided).It is unclear whether this instance would be considered a false positive or a conflicting result.No additional patient information, including treatment and outcome, was provided.

• Brand Name: ID NOW COVID-19 ASSAY
• Type of Device: MOLECULAR IVD FOR ID NOW COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 11684738
• MDR Text Key: 246483392
• Report Number: 1221359-2021-00381
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• PMA/PMN Number: EUA2000074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1