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 Use of Device Problem (1670)

Patient Problem Burning Sensation (2146)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Event Description

The customer reported their technician swabbed a positive covid patient and when technician was mixing the positive patient covid swab sample with the elution buffer, the elution buffer mixed with positive patient covid sample splashed into technician's eye.The technician states there was some brief buring sensation that shortly stopped after flushing her eyes but does not intend on seeking medical attention.

Manufacturer Narrative

A product deficiency was not reported or found.Technical service provided the safety data sheet (sds).A supplemental report will be provided if any additional is obtained.

• 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: 13390260
• MDR Text Key: 285223522
• Report Number: 1221359-2022-00662
• 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,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190-000
• Device Lot Number: 1048661
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• 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
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White