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

Catalog Number	NAT024
Medical Device Problem Codes	No Display/Image (1183); Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Smoking (1585)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation was performed at abbott diagnostics scarborough, inc.On id now instrument pn: nat-024, serial number (b)(4).Observations indicated capacitor c85 on the baseboard was damaged and shorting out the 12v power supply.There is no risk of failure causing additional damage as the instrument is designed to cut all supplied power if the 12v power supply is shorted.All pcb boards and the cover housing are ul94v-0 rated.Ul94 is the standard for flammability of plastic materials and v-0 is of the highest rating.Manufacturing and release documentation was reviewed and the instrument met all release criteria.The product review risk for the reported electrical issue is anticipated in nature and severity for id now instrument according to the product risk management file.A review of the complaints reported as no power/blank display related to id now instrument pn: nat-024 serial number (b)(4) showed no other cases.The available evidence suggests that the instrument is performing as intended as the instrument failed safely as intended by design.
Event or Problem Description
A customer reported a power issue and visible smoke with the id now instrument.The customer received the id now instrument on friday, (b)(6) 2019 and set it up the same day, with no report of using the instrument to run any samples.The customer returned to work on monday, (b)(6) 2019.The customer tried to power on the id now instrument but it would not turn on, and the customer observed smoke from the usb port.The instrument was unplugged from the power source.No other instruments were plugged into the same power source at the time of the event.The customer stated there was not a power outage over the weekend, although the customer noted the office light was on when they left on friday and was off when they returned to the office on monday.The event did not cause injury or death.No id now assay platforms were involved in the event, therefore there was no impact to patient testing.The customer returned the id now instrument to abbott diagnostics scarborough, inc.For investigation.Visible smoke is reported as a malfunction as there is potential for serious injury if the event were to recur.

• 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: 9591127
• Report Number: 1221359-2020-00001
• Device Sequence Number: 16756609
• Product Code: OOI
• UDI-Device Identifier: 00811877010821
• UDI-Public: 0100811877010821
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: NAT024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1