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	01/01/2023
Type of Reportable Event	Malfunction
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 remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
Event or Problem Description
The customer reported a spark when plugging the universal printer power cable into the wall outlet while the printer was connected to the idnow instrument.The customer stated the issue does not occur when a different power cable is used, and they believe that the cable is the issue and not the printer or instrument.The customer confirmed there was no evidence of smoke, fire, burning, or shock, and stated the spark was "mild".There was no patient involvement, and no further information was provided.
Event or Problem Description
The customer reported a spark when plugging the universal printer power cable into the wall outlet while the printer was connected to the idnow instrument.The customer stated the issue does not occur when a different power cable is used, and they believe that the cable is the issue and not the printer or instrument.The customer confirmed there was no evidence of smoke, fire, burning, or shock, and stated the spark was "mild".There was no patient involvement, and no further information was provided.
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.Through information provided by the customer, the issue was identified to be related to the accessory printer and not the id now instrument.As such, the investigation was performed on the printer power cord.The printer and printer power cord are not medical devices and are not required for use with the instrument.Visual inspection was performed on the returned printer power cord including the plastic coating and power connection points; no anomalies or physical or cosmetic damage was noted.Additionally, manufacturing records were reviewed.An exact batch record for this unit could not be identified based on the serial numbers sampled during incoming inspection of the printer.A review of 2 batch records that included adjacent serial numbers were reviewed and found no relevant non-conformances.The lot met required release specifications.The complaint is anticipated in nature and severity within the product risk file; no new hazard has been identified and it will continue to be tracked and trended.
Additional Manufacturer Narrative
Additional information: h4.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 power cord for the printer has been returned for investigation.The remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Correction: d9, h3.
Event or Problem Description
The customer reported a spark when plugging the universal printer power cable into the wall outlet while the printer was connected to the idnow instrument.The customer stated the issue does not occur when a different power cable is used, and they believe that the cable is the issue and not the printer or instrument.The customer confirmed there was no evidence of smoke, fire, burning, or shock, and stated the spark was "mild".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: 16781673
• Report Number: 1221359-2023-00649
• Device Sequence Number: 12509212
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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,Followup
• Report Date (Section B): 08/15/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 07/27/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 07/10/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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