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	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the power cord plug on the id now instrument short circuited and has a burnt area on or before (b)(6)2024.The customer confirmed there was no adverse event or effect.No additional information was reported.
Additional Manufacturer Narrative
B3: the date provided is an approximation as the exact event date was not provided 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.
Additional Manufacturer Narrative
Additional information received: d9 - device available for evaluation.D9 - date returned to mfg.H4 - device mfg date.B3: the date provided is an approximation as the exact event date was not provided 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.Upon receipt at abbott diagnostics scarborough, the cable cord of the power supply was evaluated for blackened silver prongs.The white area around the silver prongs and the bottom of the prongs themselves were observed to have blackening.There was no evidence of wire damage or fraying.An image was also provided by the customer and shows burn/char marks on a power cord.The id now instrument was not returned for evaluation.The release documentation confirmed the serial number related to the subject power supply of the instrument met the required release specifications.The current overall incident rate for id now instrument thermal decomposition of device for serial number 44ffdc1c based on the total quantity of devices distributed is (b)(4).Based on the evidence available, the instrument is performing as expected.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, an assignable cause is most likely from power surge of outlet.As per the user manual, the recommended rated input voltage: 100-240vac and output voltage: 12v.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.
Event or Problem Description
The customer reported that the power cord plug on the id now instrument short circuited and has a burnt area on or before (b)(6) 2024.The customer confirmed there was no adverse event or effect.No additional information was reported.

• 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: 19477268
• Report Number: 1221359-2024-00413
• Device Sequence Number: 4036150
• Product Code: OOI
• UDI-Device Identifier: 00811877010593
• UDI-Public: (01)00811877010593
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 07/23/2024

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: Not provided
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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