MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INSTRUMENT; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Catalog Number	NAT-024
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is still in progress.Once the investigation is complete a supplemental report will be provided.
Event or Problem Description
The customer reported the id now covid-19 instrument to be smoking when the instrument was first turned on.The id now covid-19 instrument was taken out of service.The customer confirmed there was no harm or injury due to the smoking instrument.
Additional Manufacturer Narrative
Investigation report: upon receipt at abbott diagnostics scarborough, the instrument was sent to the systems group for further investigation.Systems attempted to power on instrument and observed power was lost immediately after relay energized sending power to base board.Disassembled instrument to further investigate and observed capacitor c122 on the baseboard had failed shorting out 12-volt power supply.C122 is a 16v capacitor in a 12v circuit and is adequately sized to operate under nominal operating conditions however, it is susceptible to damage if there is a voltage transient in the power supply.In a well-designed circuit, capacitors should be rated for a minimum of 2x the intended operating voltage to allow for most transients to pass without damage.The materials surrounding the failing capacitor are either non-flammable (aluminum) or flammability rated with a minimum of 94v-2.These ratings are required for iec 61010-1 compliance.Iec 61010-1 compliance has been commissioned using tuv rhineland and tuv rhineland's safety mark is on the id now ratings label.Cause of customers complaint is a shorted capacitor from a voltage transient above its rated voltage.The release documentation for instrument part number nat024 and instrument serial number (b)(6) was reviewed; the instrument met all release criteria.The reported overheating/smoking issue is anticipated in nature and severity within the product risk file.No new hazard has been identified.In conclusion, the customer's returned instrument was replicated for smoke issue when tested at abbott diagnostics scarborough.A root cause was found to be a failure of the c122 capacitor shorting due to a voltage spike above its rated voltage.The "smoking" reported comes from the capacitor as it burns out.The failed component shorts out the 12-volt dc supply causing the instrument's power pack to shut down as an intended safety feature.This prevents the instrument from turning on.A change order was implemented to increase size of the capacitor to 25v, more than 2x operating voltage to better handle voltage transients.This device was transacted 12dec2018, prior to the capacitor size increase implemented on 09apr2021.The instrument was manufactured prior to the implementation of that change.Ased on the above summary, the investigation is deemed closed.The product will continue to be monitored and tracked.

• Brand Name: ID NOW INSTRUMENT
• 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
• MDR Report Key: 14745863
• Report Number: 1221359-2022-03280
• Device Sequence Number: 5465124
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 0100811877010593
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 05/25/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown