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	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the customer stated the exact event date is unavailable.The remainder of the investigation remains in progress.A supplemental report will be provided after investigation completion.H3 other text : return requested.No information on return receipt.
Event or Problem Description
The customer reported a spark with id now instrument when plugged directly into a power outlet.The customer stated they initially plugged in id now instrument directly to the wall outlet and instrument screen was frozen.The customer then unplugged the instrument and plugged it in different wall outlet upon which the customer reported a spark.The customer did not indicate where the spark originated from.The customer stated that there was no immediate danger and there was no injury.There was no patient involvement, and no further information was provided.
Event or Problem Description
The customer reported a spark with id now instrument when plugged directly into a power outlet.The customer stated they initially plugged in id now instrument directly to the wall outlet and instrument screen was frozen.The customer then unplugged the instrument and plugged it in different wall outlet upon which the customer reported a spark.The customer did not indicate where the spark originated from.The customer stated that there was no immediate danger and there was no injury.There was no patient involvement, and no further information was provided.
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the customer stated the exact event date is unavailable.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 rates for id now serial number (b)(6)based on the total quantity of devices distributed for failure to initialize, load applications, boot, hour glassing, stuck on abbott logo is (b)(4) and for sparking is (b)(4).Based on the evidence available, the serial number is performing as expected.Upon receipt at abbott diagnostics scarborough, the instrument was sent to the systems group for further investigation.Systems plugged instrument in but did not experience any shock or spark.Powered on instrument, observed instrument display was stuck on ¿initializing devices¿ and never reached log in screen.Disassembled to look for burnt out components and there was nothing found to contribute to a spark.The customer's complaint of sparking was not replicated and was not confirmed.

• 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: 17390765
• Report Number: 1221359-2023-01287
• Device Sequence Number: 18364032
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 07/11/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 10/27/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown