MAUDE Adverse Event Report: KAZ USA, INC. BRAUN

Model Number IRT-6500

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

Patient Problem Fever (1858)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

A consumer reported that her thermometer had allegedly given false negative readings on their son.The device was giving readings 5-7 degrees lower than the patient's actual temperature.The patient 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.

Manufacturer Narrative

The readings were within the 0.2 degree f tolerance for accuracy.These are passing results.The alleged malfunction could not be duplicated in testing, and there were no defects found in the returned product.

Event Description

A consumer reported that her thermometer had allegedly given false negative readings on their son.The device was giving readings 5-7 degrees lower than the patient's actual temperature.The patient was brought to a hospital and a fever was confirmed.

• Brand Name: BRAUN
• Manufacturer (Section D): KAZ USA, INC.; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch blvd.; ste. 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 5369245
• MDR Text Key: 36250253
• Report Number: 1314800-2016-00001
• 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
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• 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: 12/09/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention