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

Catalog Number	NAT024
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was evaluated for the reported issue which was replicated utilizing a scanner and the following sequence of activities: power cycle the instrument and scan id barcode before the data entry screen is displayed.A second scan of the barcode will correctly display the id.If the users wait for the data screen to fully load before pressing the scanner button, the issue will not occur.The issues appear to be easier to create when using this latest version but can also be recreated with earlier versions.It does not appear to be linked to scanner type and has been inherent in the software since launch.Additionally, a customer provided photo for a barcode that failed was also reviewed to eliminate the possibility that the barcode or scanner would have contributed to the customer's issue.There was no obvious indication of a problem with the barcode print quality, dimensions, etc.The issue was isolated to the mono (c#) framework runtime in relation to the de-queue of the code which was found to be occurring out of order.As the de-queues work on the graphical user interface (gui) thread, the delay (or thread being used for page transitioning and rendering) is causing the de-queuing to come out of order.This can manifest as an unacknowledged key press (the barcode scanner emulates a keyboard), which appears to the user as an id that has out of order characters, truncated ids, and missed capitalization of characters.A review of the complaints reported for this issue (confirmed and unconfirmed) showed that the complaint rate is 0.0003%.Additionally, the risk evaluation of this event identified the likelihood of occurrence is remote and the likelihood of injury is improbable.Per the id now user manual and graphical user interface (gui), after scanning the barcode, the user should confirm the patient id after scanning.The customer has to click 'ok' to confirm the patient id that is scanned is correct.Risk of not following the user manual or gui will result in the incorrect scan not being identified.If the users employ middleware to manage data transmission from the id now instrument to a database, it is more unlikely that the incorrect id will be detected as this is an automated process.Further action is being taken to address this issue through our corrective and preventive action process.Please note: the attached pictures represent the customer replicating the issue and is not the patient involved in this event.
Event or Problem Description
Customer ((b)(6)) reported an issue with the id now instrument barcode reader (pn eq001001, manufactured by opticon).The customer stated after scanning the patient id, the numbers were swapped.The swapped numbers aligned to a different patient.The operator did not confirm patient id was correct before entering the negative result on a patient that had orders, but had yet to be tested.This error resulted in a negative id now covid-19 result being reported on an incorrect patient.Additional information, include patient treatment, impact and outcome were unknown.
Additional Manufacturer Narrative
Corrected data/additional information: actions to mitigate this issue taken in august 2020 were inadvertently omitted from the previous summary.A routine software update (version 6.1.34) occurred in august 2020 to allow the user to run updated tests, to prevent timeouts of large operator lists, to prevent patient demographic information persisting, and to address the possibility of early scanned barcodes.

• 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
• MDR Report Key: 12683571
• Report Number: 1221359-2021-03232
• Device Sequence Number: 4233205
• Product Code: OOI
• UDI-Device Identifier: 00811877010821
• UDI-Public: 0100811877010821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/02/2021

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: 05/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1