MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 INSTRUMENT; ID NOW INSTRUMENT NAT-024

Catalog Number	NAT-024
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
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.The id now covid-19 instrument was taken out of service.
Additional Manufacturer Narrative
Correction: correct the date of the first supplemental report in b4 to 05aug2022.
Additional Manufacturer Narrative
Additional information: g1 (telephone and fax) corrected information: d4 (serial number) investigation conclusion: 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 pn: nat-024 and instrument serial number (b)(6) was reviewed and the instrument met all release criteria.In conclusion, the customer's returned instrument was replicated for the smoke issue when tested at abbott diagnostics scarborough.A root cause of the customer's complaint is a failure of the c122 capacitor shorting due to a voltage spike above its rated voltage.The smoking of the instrument is the result of the thermal destruction of the capacitor.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.Change was implemented to increase size of capacitor to 25v, more than 2x operating voltage to better handle voltage transients.This instrument was transacted in (b)(6) 2020.The change to increase size of capacitor to 25v was implemented (b)(6) 2021.The instrument was manufactured before the implementation of that change.Based on the above summary, the investigation is deemed closed.The product will continue to be monitored and tracked.

• Brand Name: ID NOW COVID-19 INSTRUMENT
• Common Device Name: ID NOW INSTRUMENT NAT-024
• 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: 13253156
• Report Number: 1221359-2022-00175
• Device Sequence Number: 20021919
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 0100811877010593
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2022

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
• Device Lot Number: F609AE1C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 07/14/2022; 08/05/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 08/05/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2020
• 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