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	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported visible smoke coming from the id now instrument on (b)(6) 2025.The customer indicated that the instrument had not been powered on in a long time and that when it was powered on, the customer reported seeing smoke from the back of the id now instrument and that it smelled like a burnt wire.There was no evidence of 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
The remainder of the investigation is in progress.A supplemental report will be provided pending completion, or upon receipt of new information.
Additional Manufacturer Narrative
Additional information: d9 - device available for evaluation and date returned to mfg.The remainder of the investigation is in progress.A supplemental report will be provided pending completion, or upon receipt of new information.
Event or Problem Description
The customer reported visible smoke coming from the id now instrument on (b)(6) 2025.The customer indicated that the instrument had not been powered on in a long time and that when it was powered on, the customer reported seeing smoke from the back of the id now instrument and that it smelled like a burnt wire.There was no evidence of 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
Additional/updated information: b5 (id now instrument was not powering on).Testing was performed at abbott diagnostics scarborough, inc.The instrument was inspected and customers reported issue for visible smoke was not replicated.The instrument was attempted to be powered on and observed relay click and led flashes 3 times.Instrument does not power up.Disassembled instrument to look for corrosion, loose connections or burnt out components.No burnt odor or smoking was observed.There was no physical issues found on boards and connections are all seated firmly.Log files were reviewed that cover manufacture through 24apr2024.There is no evidence to support power failure or burning odor in recorded logs.A definitive assignable cause cannot be determined from physical investigation or log file review.The incident rates (complaints per million (cpm)) for smoking, device emits odor and failure to power on when compared to established thresholds, indicates the instrument is performing as expected.The release documentation for instrument pn: nat-024 and instrument serial number (b)(6) was reviewed and the instrument met all release criteria.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue of visible smoke, a definitive root cause could not be determined from the investigation.
Event or Problem Description
The customer reported visible smoke coming from the id now instrument on 13jan2025.The customer indicated that the instrument had not been powered on in a long time and was not powering on, the customer reported seeing smoke from the back of the id now instrument and that it smelled like a burnt wire.There was no evidence of 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
Correction - investigation conclusion: the release documentation for instrument pn: nat-024 and instrument serial number (b)(6) was reviewed, and the instrument met all release criteria.Testing was performed at abbott diagnostics scarborough, inc.The instrument was inspected and customer¿s reported issue for visible smoke was not replicated.The instrument was attempted to be powered on and observed relay clicks and led flashes 3 times.Instrument does not power up.Disassembled instrument to look for corrosion, loose connections or burnt-out components.No burnt odor or smoking was observed.There were no physical issues found on boards and connections are all seated firmly.Log files were reviewed.There is no evidence to support power failure or burning odor in recorded logs.A definitive assignable cause cannot be determined from physical investigation or log file review.The incident rate for smoking and device emits odor when compared to established thresholds, indicate the instrument is performing as expected as there were 20 complaints in the prior 12 months for this failure mode.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue of visible smoke; a definitive root cause could not be determined from the investigation.
Event or Problem Description
The customer reported visible smoke coming from the id now instrument on (b)(6)2025.The customer indicated that the instrument had not been powered on in a long time and was not powering on, the customer reported seeing smoke from the back of the id now instrument and that it smelled like a burnt wire.There was no evidence of visible spark or fire.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: 21209533
• Report Number: 1221359-2025-00021
• Device Sequence Number: 3851796
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: (01)00811877010593
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 12/08/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 01/24/2025; 03/13/2025; 12/05/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/03/2025; 03/17/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown