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	Fire (1245); Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the id now instrument sparked when plugged directly into a wall outlet during routine inspection.The instrument was then powered on and smoke was observed by the customer.A short time after the instrument was powered on, the customer reported seeing a small fire on the unit.The customer stated no one was injured and the device was powered off and will not be powered on.There was no patient involvement, and no further information was provided.
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
Additional Manufacturer Narrative
The customer reported that their id now instrument (b)(6) had smoke, sparks, and fire when attempting to power on while id now instrument (b)(6) had a software issue of loading applications.The customer confirmed that no one was injured, the instrument was powered off and would not be powered on.Ts instructed the customer to perform a hard reboot of the instrument by connecting it to a wall outlet, but both issues persisted.The instruments were returned.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) ,the current overall incident rate for id now instrument is burning /on fire / exploded for serial number (b)(6) based on the total quantity of devices distributed is (b)(4) and the current overall incident rate for id now instrument is sparking for serial number (b)(6) based on the total quantity of devices distributed is (b)(4).Based on the evidence available, the serial number is performing as expected.In conclusion, the customer¿s returned instrument was verified to have a short that may have caused the customers reported issue of smoke, sparks, and fire when tested at abbott diagnostics scarborough.An assignable cause of the customer's complaint was a failure of the c85 shorting out the 12vdc.The assignable cause of the customer's complaint of not powering on is a failure of the c85 capacitor shorting due to a voltage spike above its rated voltage.
Event or Problem Description
The customer reported that the id now instrument sparked when plugged directly into a wall outlet during routine inspection.The instrument was then powered on and smoke was observed by the customer.A short time after the instrument was powered on, the customer reported seeing a small fire on the unit.The customer stated no one was injured and the device was powered off and will not be powered on.There was no patient involvement, and no further information was provided.

• 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: 17130589
• Report Number: 1221359-2023-01211
• Device Sequence Number: 7377125
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• 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): 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: 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: 05/24/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 06/14/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown