MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INSTRUMENT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number	NAT-024
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 experiencing smoke coming from the id now instrument.As a result, the instrument was unplugged.The customer confirmed that no one was involved or injured in this event.
Additional Manufacturer Narrative
The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
Additional Manufacturer Narrative
The customer reported that their id now instrument serial number 1efdd81c was sparking with smoke.The customer later confirmed that the instrument did not produce any sparks and that no one was injured by the smoke.The release documentation for instrument pn: nat-024 and instrument serial number 1efdd81c was reviewed and the instrument met all release criteria.Upon receipt at abbott diagnostics scarborough, 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 c85 on the baseboard had failed shorting out 12-volt power supply.C85 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.In conclusion, the customer's returned instrument showed evidence that would cause the instrument to smoke due to the destruction of the c85 capacitor when tested at abbott diagnostics scarborough.A root cause of customers complaint is a failure of the c85 capacitor shorting due to a voltage spike above its rated voltage.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.

• Brand Name: ID NOW INSTRUMENT
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST 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: 13262560
• Report Number: 1221359-2022-00309
• Device Sequence Number: 4760973
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 04/05/2022; 10/06/2023
• Initial Report FDA Received Date: 01/15/2022
• Supplement Report FDA Received Date: 04/15/2022; 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• 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