MAUDE Adverse Event Report: ARC DEVICES USA INC. ARC INSTATEMP; INFRARED THERMOMETER

Model Number	CF1-0196
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Fever (1858)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The consumer/mother reported their thermometer was giving false negative readings.The device allegedly was reading 5-6 degrees lower than the child's actual temperature.The child was treated at an emergency room where a fever was confirmed.The consumer also stated that the child had a febrile seizure.Arc devices has requested that the product be returned to our company for lab analysis.

• Brand Name: ARC INSTATEMP
• Common Device Name: INFRARED THERMOMETER
• Manufacturer (Section D): ARC DEVICES USA INC.; 1200 n. federal highway; suite 207; boca raton FL 33432
• MDR Report Key: 6664576
• Report Number: 3011197139-2017-00100
• Device Sequence Number: 1972802
• Product Code: FLL
• UDI-Device Identifier: 05391525570006
• UDI-Public: (01)05391525570006(21)
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: CF1-0196
• Device Catalogue Number: CF1-0196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 MO