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

Model Number IRT-3020

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 7 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.

Manufacturer Narrative

The thermometer was set to calibration mode for testing temperatures of the blackbody.Black body setting degrees celsius: 36.0, irt-3020 degrees celsius: 35.8; black body setting degrees celsius: 38.5, irt-3020 degrees celsius: 38.3; black body setting degrees celsius: 41.0, irt-3020 degrees celsius: 40.9.The readings were within the 0.2 degrees celsius 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.

• Brand Name: BRAUN
• Type of Device: THEROMETER
• Manufacturer (Section D): KAZ USA, INC.; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 5021275
• MDR Text Key: 24296941
• Report Number: 1314800-2015-00063
• 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: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• 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: 29913
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Patient Age: 17 MO