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

Catalog Number 190-000

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

The customer reported an allergic reaction after performing the sars-cov-2 nucleocapsid on patient with a id now covid 19 control swab.The customer reported that reactions were brain pains, nigh sweats the evening after, and closing of throat.Trouble breathing, lack of comprension and tiredness.The patient was provided basic treatment and advised to follow up with general practioner.

• Brand Name: ID NOW COVID-19
• Type of Device: MOLECULAR IVD FOR ID NOW COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCABOROUGH, INC.; 10 southgate road; scaborough 04074
• Manufacturer Contact: kindra sudduth ; abbott diagnostics scaborough,; 10 southgate road; scarborough, ME 04074 ; 8813888803
• MDR Report Key: 11606459
• MDR Text Key: 249069258
• Report Number: 1221359-2021-00863
• Device Sequence Number: 1
• Product Code: QJR
• UDI-Device Identifier: 10811877011290
• UDI-Public: 10811877011290
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190-000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening
• Patient Age: 30 YR
• Patient Weight: 65