MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY BRAUN; IRT6520

Model Number	IRT6520
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Fever (1858)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Kaz usa, inc.Has requested additional information regarding this incident, and also that the product be returned to our company for testing, but it has not yet been received.
Event or Problem Description
A hospital reported that their thermometer had allegedly given a false negative reading on a patient who was febrile due to high leukocytes caused by an infection.The device allegedly gave a reading of 34°c, and a fever of 39°c was confirmed by a medical professional using a mercury thermometer.No information was provided on the diagnosis or current status of the patient.The only known information provided was that a fever was confirmed by a medical professional, and our device was giving false negative readings.Kaz usa, inc.Has requested that the product be returned to our company for testing.

• Brand Name: BRAUN
• Common Device Name: IRT6520
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• Manufacturer Contact: bethany lee ; 400 donald lynch boulevard; suite 300; marlborough, MA 01752
• MDR Report Key: 20814091
• Report Number: 1314800-2024-00022
• Device Sequence Number: 9940605
• Product Code: FLL
• UDI-Device Identifier: 00328785001914
• UDI-Public: (01)00328785001914
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: IRT6520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown