MAUDE Adverse Event Report: KAZ USA, INC. BRAUN; THERMOMETER

Model Number IRT-3020

Device Problems False Negative Result (1225); Low Test Results (2458)

Patient Problem Fever (1858)

Event Date 12/21/2015

Event Type  malfunction  

Event Description

The consumer reported their thermometer was giving false negative reading on their child.The device allegedly was reading 8 - 9 degrees lower than the child's actual temperature.The child was treated at a hospital, where it was confirmed that they had a fever.There were no complications form this incident, and the patient is doing fine now.Kaz usa, inc.Has requested that the product be returned to our company for lab analysis.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; marborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch blvd. ; suite 300; marlborough , MA 01752 ; 5084907236
• MDR Report Key: 5407080
• MDR Text Key: 37437244
• Report Number: 1314800-2016-00004
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-3020
• Device Lot Number: 23314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1