MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INSTRUMENT

Catalog Number	NAT024
Medical Device Problem Codes	Smoking (1585); Temperature Problem (3022)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The id now instrument has not been returned by the customer, therefore a device evaluation/investigation was not performed.Manufacturing batch records and release documentation for part number nat-024 / serial number (b)(4) were reviewed.This lot met the required release specifications.A review of the complaints indicated there are no other cases related to instrument function reported for serial number (b)(4).Abbott diagnostics (b)(4), inc.Was unable to determine the exact root cause of the reported issue.The available evidence suggests that this instrument sn is performing according to label claims.The exact root cause of the reported issue could not be determined.Attempts to gain additional information were not successful.
Event or Problem Description
A customer reported observing smoke from the id now instrument.The customer reported when turning on one of the id now instruments for training purposes, smoke was emitted from the on button.The customer stated the instrument was unplugged immediately.The customer stated they attempted to turn the instrument back on after plugging it in, but the screen remained off and the power supply light flashed once.The customer confirmed there were no injuries due to the observed smoke.The customer confirmed there were no visible flames.Due to the report of visible smoke, this event shall be considered reportable as a malfunction.
Additional Manufacturer Narrative
The id now instrument was returned for further investigation by abbott diagnostics scarborough, inc.The release documentation for instrument pn: nat-024 and instrument serial number (b)(6) was reviewed and the instrument met all release criteria.Upon receipt at abbott diagnostics scarborough, the instrument was inspected and customers reported issue was found to have replicated and sent to the systems group for further investigation.Systems observed capacitor c85 on the baseboard was damaged and shorting out the 12v power supply.Capacitor c85 is located right below the side usb port behind the power button.When it shorted, smoke was released and escaped out of the power button.There is no risk of failure causing additional damage other then the small amount of smoke observed by the customer.Once the 12v power supply is shorted, the instrument's power pack instantly cuts off all supplied power as an intended safety feature, therefore preventing instrument from turning on.
Event or Problem Description
There is no additional event or problem description for this supplemental report.The supplemental information is exclusive to the investigation and is described in h10.

• Brand Name: ID NOW INSTRUMENT
• Common Device Name: ID NOW
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 10126264
• Report Number: 1221359-2020-00084
• Device Sequence Number: 11494257
• Product Code: OOI
• UDI-Device Identifier: 00811877010821
• UDI-Public: 0100811877010821
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191534
• 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): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NAT024
• Device Lot Number: 3B788F1B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1