NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER

Report

• Report Number: MW5092047
• Event Type: Malfunction
• Date Received: January 6, 2020
• Date of Event: January 2, 2020
• Report Date: January 2, 2020
• Manufacturer: MEDTRONIC INDICATORS, INC.
• Product Code: FQZ
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Location: CA, US
• Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

WE TRIED USING THE NEXTEMP SINGLE USE THERMOMETERS ON 3 INDIVIDUALS TO SEE IF THEY WERE FEVERISH. I ALSO PUT ONE DEVICE INTO HOT WATER TO SEE IF IT WAS WORKING. NONE OF THE DEVICES PROVIDED TEMPERATURE INDICATION. THE PHOTO SHOWS AN UNUSED DEVICE AND A USED DEVICE JUST USED ON MYSELF. I AM NOT FEVERISH AND THESE DEVICES CANNOT BE DISTINGUISHED. NOTE THAT ENTIRE BOX OF 100 DEVICES HAS BEEN STORED IN A REFRIGERATOR (BELOW THE STATED 30C) SINCE PURCHASE. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18800	NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER	THERMOMETER CLINICAL COLOR CHANGE	FQZ	MEDTRONIC INDICATORS, INC.	REORDER CODE 1112	07555
18801	NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER	THERMOMETER CLINICAL COLOR CHANGE	FQZ	MEDTRONIC INDICATORS, INC.	REORDER CODE 1112	07555
18802	NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER	THERMOMETER CLINICAL COLOR CHANGE	FQZ	MEDTRONIC INDICATORS, INC.	REORDER CODE 1112	07555
18803	NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER	THERMOMETER CLINICAL COLOR CHANGE	FQZ	MEDTRONIC INDICATORS, INC.	REORDER CODE 1112	07555
18804	NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER	THERMOMETER CLINICAL COLOR CHANGE	FQZ	MEDTRONIC INDICATORS, INC.	REORDER CODE 1112	07555

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 1

• Product Quality Problem

Type of report · 1

• Initial submission