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

Model Number IRT-3020

Device Problem False Negative Result (1225)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

The consumer reported their thermometer was giving false negative readings on their child for several days.The device allegedly was reading 3-4 degrees lower than the child's actual temperature.The child was treated at a (b)(6) facility where it was confirmed that they had a fever.There were no complications from this incident, and the pt is doing fine now.Kaz usa, inc has requested that the product be returned to our company for lab analysis.

Manufacturer Narrative

Root cause analysis: after cleaning, all readings are within specification.These are passing results.The cause of the false negative reading was a dirty lens.The instructions for proper use state that the thermometer should be cleaned in between uses, as necessary.

• 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: 5165671
• MDR Text Key: 28910603
• Report Number: 1314800-2015-00069
• 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,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• 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: 24313RAD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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): Other; Required Intervention