MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INSTRUMENT US; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Catalog Number	NAT-024
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported visible smoke coming from the id-now instrument on or before 06aug2024.There was no visible spark or fire.There was no patient involved.The customer confirmed there was no injury or harm associated with the smoke.
Additional Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
Additional Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided.Correction: b5- additional details added to b5 section.Investigation results: the release documentation for instrument pn: nat-024 and instrument serial number (b)(6) was reviewed and the instrument met all release criteria.The current overall incident rate for id now instrument or device smoking for serial number (b)(6) based on the total quantity of devices distributed is (b)(4).Based on the evidence available, the instrument is performing as expected upon receipt at abbott diagnostics scarborough, the instrument was inspected and the customers reported issue could not be verified.The instrument was disassembled in order to look for burnt components.There was no burnt smell or burnt components observed.The instrument was powered on and the display was observed to be stuck on "loading application" and never reached log in screen.Burnt odor or visible smoke was unable to be identified.In conclusion, the customer¿s returned instrument could not be verified for burnt or smoking issue when tested at abbott diagnostics scarborough.Abbott diagnostics scarborough and was unable to determine the exact root cause of the reported issue.
Event or Problem Description
The customer reported visible smoke coming from the id-now instrument on or before (b)(6) 2024.The customer reported a power outage happened in their area at the time of the event.There was no visible spark or fire.After smoke was observed, the instrument no longer worked.There was no patient involved.The customer confirmed there was no injury or harm associated with the smoke.

• Brand Name: ID NOW INSTRUMENT US
• Common Device Name: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• 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: 20039275
• Report Number: 1221359-2024-00569
• Device Sequence Number: 6508035
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: (01)00811877010593
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NAT-024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown