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	10/17/2022
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 smoke coming from the id now instrument.Per the customer, the instrument was smoking after it was turned on and did not occur during use.There was no visible spark or fire.There was no patient involvement and the customer confirmed there was no injury or harm associated with the smoke.
Additional Manufacturer Narrative
Two photos provided by the customer were reviewed.The device serial number was verified; however, the customer complaint could not be confirmed based on the photos.The release documentation for instrument part number: nat-024 and instrument serial number: (b)(6) was reviewed and the instrument met all release criteria.A review of the complaints reported as smoking instrument based on total quantity distributed showed that the complaint rate is (b)(4).Technical services made three attempts for the return of the instrument however the customer was unresponsive.As such, further investigation was not able to be performed.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.H3 other text: device not returned.
Event or Problem Description
The customer reported smoke coming from the id now instrument.Per the customer, the instrument was smoking after it was turned on and did not occur during use.There was no visible spark or fire.There was no patient involvement and 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: 15724580
• Report Number: 1221359-2022-10054
• Device Sequence Number: 7251575
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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