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

Catalog Number 190-000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

This investigation is still in progress.Once the investigation is complete a supplemental report will be provided.

Event Description

The customer reported an allergic reaction to id now covid-19 assay swab.Although requested, additional information, including patient treatment and outcome was not 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: elissa zavorotny ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12496883
• MDR Text Key: 272232526
• Report Number: 1221359-2021-02682
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA2000074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190-000
• 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
• Patient Outcome(s): Other