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

Model Number IRT-6500

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

Patient Problem Fever (1858)

Event Date 08/11/2015

Event Type  malfunction  

Event Description

A consumer reported that her thermometer had allegedly given false negative readings on an infant.The device was reading 3.4 degrees lower than the pt's actual temperature.The pt was brought to a hospital and a fever was confirmed.Kaz usa, inc, has requested that the device be returned to our company for further investigation.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd.; southborough, MA 01772 ; 5084907236
• MDR Report Key: 5079823
• MDR Text Key: 26070568
• Report Number: 1314800-2015-00064
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Not Applicable
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-6500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 14 MO