MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INSTRUMENT US; 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	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported on smoking instrument with id now covid-19 instrument on (b)(6) 2022.The customer confirmed there was no harm or injury due to the smoking instrument.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Additional Manufacturer Narrative
Updated data: h3: device evaluated by manufacturer.H3: reason device not evaluated by manufacturer.The customer reported that their id now instrument serial number 5f470d1b was smoking.The customer confirmed that the instrument was connected to a direct wall outlet.The instrument was returned for investigation.The release documentation for instrument pn: nat-024 and instrument serial number 5f470d1b was reviewed and the instrument met all release criteria.The current overall incident rate for instrument or device smoking id now based on the total quantity distributed is 0.0683%.Based on the evidence available, the instrument is performing as expected.Upon receipt at abbott diagnostics scarborough, the instrument was inspected and found to be contaminated with amplicon and scrapped without further investigation.In conclusion, the customer¿s returned instrument could not verify the smoking the issue when tested at abbott diagnostics scarborough.Because the customer issue was not replicated, an assignable cause could not be determined.D4: udi (b)(4).
Event or Problem Description
The customer reported on smoking instrument with id now covid-19 instrument on 21nov2022.The customer confirmed there was no harm or injury due to the smoking instrument.No additional patient information, including treatment and outcome, was provided.

• Brand Name: ID NOW INSTRUMENT US
• 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 ; 6613888803
• MDR Report Key: 15959678
• Report Number: 1221359-2022-10297
• Device Sequence Number: 5107350
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown