MAUDE Adverse Event Report: KAZ, INC. BRAUN

Model Number IRT-3020

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 09/01/2015

Event Type  malfunction  

Event Description

The consumer reported their therometer was giving false negative readings on their child.The device allegedly was reading 3-4 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 from 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
• Manufacturer (Section D): KAZ, INC.; marlborough MA 01752
• Manufacturer Contact: sonja wilkinson ; 400 donald lynch blvd., ste. 300; marlborough, MA 01752
• MDR Report Key: 5292511
• MDR Text Key: 33505406
• Report Number: 1314800-2015-00081
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• 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: 01911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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