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 Codes	Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation remains in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported that the id now covid-19 instrument had smoke coming out of it and there is a lingering burned smell.The id now covid-19 instrument was in a power cycle and will no longer turn on.There was no harm due to the issue that caused the smoke and burned smell, or from the smoke and burned smell.There was no patient involvement.
Event or Problem Description
The customer reported that the id now covid-19 instrument had smoke coming out of it and there is a lingering burned smell.The id now covid-19 instrument was in a power cycle and will no longer turn on.There was no harm due to the issue that caused the smoke and burned smell, or from the smoke and burned smell.There was no patient involvement.
Additional Manufacturer Narrative
A batch history record review was not performed as no certificate of analysis (coa) was generated for this instrument which was a research and development internal release per abbott internal procedure.Upon receipt at abbott diagnostics scarborough, the instrument was sent to the systems group for further investigation.Customers complaint was replicated but there is no odor, smoke or burning smell present.Internal examination revealed no visible damage to any components that look like a burn out and there are no loose connections.Inline fuse is still good which shows no overloading occurred.The current overall incident rate for instrument emits burnt odor on the id now based on the total quantity distributed is (b)(4).Based on the evidence available, the instrument is performing as expected.In conclusion, the customer¿s returned instrument was not replicated for smoke or burning smell when tested at abbott diagnostics scarborough.The product will continue to be monitored and tracked.

• 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: 16645169
• Report Number: 1221359-2023-00560
• Device Sequence Number: 20389015
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: Other
• Device Catalogue Number: NAT-024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 08/05/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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