MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. DIGIVAL INSTRUMENT (OUS); DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number	LFR-000
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, list number lfr-000 that has a similar product distributed in the us, list number lfr-024.B3: the date indicated is an approximation as the exact event dates were not provided.The remainder of the investigation is in progress.A supplemental report will be provided pending completion, or upon receipt of new information.
Event or Problem Description
The customer reported that the power cord insulation was torn, exposing the wire within and that the cord sparked from the damaged area of the digival instrument power cord on an unknown date.An abbott field support representative confirmed that there have been no health problems or any harm/injury to the customer as a result of this issue.
Event or Problem Description
The customer reported that the power cord insulation was torn, exposing the wire within and that the cord sparked from the damaged area of the digital instrument power cord on an unknown date.An abbott field support representative confirmed that there have been no health problems or any harm/injury to the customer as a result of this issue.
Additional Manufacturer Narrative
This report is being filed on an international product, list number lfr-000 that has a similar product distributed in the us, list number lfr-024.B3: the date indicated is an approximation as the exact event dates were not provided.Corrected data: g4 - pma/510(k) #.Investigation summary: an investigation was performed by abbott diagnostics scarborough, inc.In which the instrument power cable was confirmed to be damaged/frayed upon review of a customer provided image.The damage was determined to be cause by user mishandling and no product defect was found.Damaged cords present no danger to the user.The supply output is 12v and the design contains a failsafe which shuts down the supply in the event of electrical short circuit resulting from exposed wiring.The product will continue to be monitored and tracked.

• Brand Name: DIGIVAL INSTRUMENT (OUS)
• Common Device Name: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: 23292076
• Report Number: 1221359-2025-00439
• Device Sequence Number: 20029625
• Product Code: PSZ
• UDI-Device Identifier: 00811877010623
• UDI-Public: (01)00811877010623
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K162642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: LFR-000
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown