MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW INSTRUMENT; MOLECULAR IVD FOR ID NOW COVID-19

Catalog Number	NAT024
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.Reference mfr no: 1221359-2022-03373.
Event or Problem Description
The customer reported an issue with the id now instrument and the results that are being printed for two patients.This mfr.Report addresses patient two (2) of two (2).As per the customer testing was performed on id now instrument on a unknown date, generated a negative result on the instrument and printed a positive result which were not the same.Customer confirmed the id's matched the patient on the instrument and the printed results.Repeat testing was not performed.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclussion to the previously reported event.Technical service confirmed that the instrument was connected to rals link.The customer later on stated the issue has been resolved and will not be sending in needed information.Issue resolved and no further action required.The product will continue to be monitored and tracked.

• Brand Name: ID NOW INSTRUMENT
• Common Device Name: MOLECULAR IVD FOR ID NOW COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough,; ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough,; 6613888803
• MDR Report Key: 15021974
• Report Number: 1221359-2022-03374
• Device Sequence Number: 16773774
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 0100811877010593
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/22/2022

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: NAT024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/22/2022
• 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