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

Model Number CF1-0196

Device Problem Low Sensing Threshold (2575)

Patient Problems Fever (1858); Patient Problem/Medical Problem (2688)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

The customer reported their thermometer was giving false negative readings.The device was reported as reading 4-5 degrees lower than the child's temperature taken later with a different type of thermometer.The customer reports she took her child to the hospital.There were no reported complications from this incident.Arc has requested the return of the device for investigation.

• Brand Name: ARC INSTATEMP
• Type of Device: THERMOMETER
• Manufacturer (Section D): ARC DEVICES USA INC.; 1200 north federal highway; suite 207; boca raton FL 33432
• Manufacturer (Section G): ARC DEVICES USA INC.; 1200 north federal highway; suite 207; boca raton FL 33432
• Manufacturer Contact: mary ann greenawalt ; 1200 north federal highway; suite 207; boca raton, FL 33432 ; 5612826074
• MDR Report Key: 7264878
• MDR Text Key: 100005466
• Report Number: 3011197139-2018-00102
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• 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: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: CF1-0196
• Device Catalogue Number: CF1-0196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1