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

Model Number CF1-0196

Device Problem Device Sensing Problem (2917)

Patient Problem Fever (1858)

Event Date 05/24/2017

Event Type  Injury  

Event 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
• Type of Device: INFRARED THERMOMETER
• Manufacturer (Section D): ARC DEVICES USA INC.; 1200 n. federal highway; suite 207; boca raton FL 33432
• Manufacturer (Section G): ARC DEVICES USA INC.; 1200 n. federal highway; suite 207; boca raton FL 33432
• Manufacturer Contact: mary greenawalt ; 1200 n. federal highway; suite 207; boca raton, FL 33432 ; 5612826074
• MDR Report Key: 6664576
• MDR Text Key: 78308330
• Report Number: 3011197139-2017-00100
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 05391525570006
• UDI-Public: (01)05391525570006(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: CF1-0196
• Device Catalogue Number: CF1-0196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 MO