FDA Adverse Event Malfunction Summary report: N

BRAUN

MDR report key: 20814091 · Received November 30, 2024

Report

Report Number: 1314800-2024-00022
Event Type: Malfunction
Date Received: November 30, 2024
Date of Event: October 20, 2024
Report Date: November 30, 2024
Manufacturer: KAZ USA, INC., A HELEN OF TROY COMPANY
Product Code: FLL
UDI-DI: 00328785001914
PMA / PMN Number: K103800
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2618074	BRAUN	IRT6520	FLL	KAZ USA, INC., A HELEN OF TROY COMPANY	IRT6520		00328785001914

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention\| O\| H