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	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported visible smoke coming from the id-now instrument when the test base holder overheated and melted.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
Additional information received: d9 - date returned to mfg, h4 investigation summary: upon receipt at abbott diagnostics scarborough, the instrument was evaluated.The rotor insulator was identified to have bubbles and cracks in the plastic, however the cause was linked to moisture present in the plastic resin during injection molding by the part supplier.There was no evidence of melting.The instrument was powered on and remained in an idle state for several minutes, but there was no smoke present.As a precaution, the instrument's safety would remove power to the heaters if temperatures rose above 100c; the device heaters were tested and recorded normal operating temperatures.The log files were reviewed there were no instances of overheating recorded.In conclusion, the customer¿s returned instrument was functioning properly when tested and there was no evidence of smoke.Abbott diagnostics scarborough and was unable to determine the exact root cause of the reported issue.H8.
Event or Problem Description
The customer reported visible smoke coming from the id-now instrument when the test base holder overheated and melted.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
Correction: h6 investigation conclusion code - d17 - supplier issue.Investigation summary: upon receipt at abbott diagnostics scarborough, the instrument was evaluated.The rotor insulator was identified to have bubbles and cracks in the plastic, however the cause was linked to moisture present in the plastic resin during injection molding by the part supplier.There was no evidence of melting.The instrument was powered on and remained in an idle state for several minutes, but there was no smoke present.As a precaution, the instrument's safety would remove power to the heaters if temperatures rose above 100c; the device heaters were tested and recorded normal operating temperatures.The log files were reviewed there were no instances of overheating recorded.In conclusion, the customer¿s returned instrument was functioning properly when tested and there was no evidence of smoke.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 when the test base holder overheated and melted.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.

• 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: 16034732
• Report Number: 1221359-2022-10384
• Device Sequence Number: 17512167
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• 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: 12/20/2022
• Supplement Date Received by Manufacturer: 05/10/2023; 12/05/2025
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 06/02/2023; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown