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

Model Number IRT-4520

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

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

A consumer reported that she has two thermometers, and that both of them had allegedly given false negative readings on their son.The device both allegedly gave readings 4-5 degrees lower than the patient's actual temperature.The patient was brought to a hospital and a fever streptococcus were confirmed.Kaz usa, inc.Has requested that both devices be returned to our company for further investigation.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch blvd.; suite 300; marlborough, MA 01752 ; 5084907236
• MDR Report Key: 5427316
• MDR Text Key: 38084736
• Report Number: 1314800-2016-00009
• 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
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-4520
• Device Catalogue Number: N/A
• Device Lot Number: 02913 & 27712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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
• Patient Outcome(s): Other; Required Intervention