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

Catalog Number	NAT-000
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported frayed cord at connection point with id now instrument which sparked when plugged in.The customer stated that there was no immediate danger and there was no injury.There was no patient involvement, and no further information was provided.
Additional Manufacturer Narrative
The date indicated is an approximation as the customer stated the exact event date is unavailable.This report is being filed on an international product, list number nat-000 that has a similar product distributed in the us, list number nat-024.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the customer stated the exact event date is unavailable.This report is being filed on an international product, list number nat-000 that has a similar product distributed in the us, list number nat-024.The customer reported that their id now instrument had a frayed power cord.Based on the issue, a replacement cord was provided to the customer.Issue resolved and no further investigations required.A product deficiency was not identified or reported for the id now instrument; therefore, no additional investigation was required.This instrument power cable was confirmed to be damaged/frayed and falls within the scope of abbott internal procedures which determined damage occurred due to user mishandling and that no product defect was found.Damaged cords present no danger to the user.The supply output is only 12 vdc and the design contains a failsafe which shuts down the supply in the event of electrical short circuit resulting from exposed wiring.Based on the above summary, the investigation is deemed closed.An overall product deficiency has not been identified.The product will continue to be monitored and tracked.H3 other text : device not returned.
Event or Problem Description
The customer reported frayed cord at connection point with id now instrument which sparked when plugged in.The customer stated that there was no immediate danger and there was no injury.There was no patient involvement, and no further information was provided.

• 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
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 16948531
• Report Number: 1221359-2023-01140
• Device Sequence Number: 6555253
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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-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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown