MAUDE Adverse Event Report: MEDTRONIC INDICATORS, INC. NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER; THERMOMETER CLINICAL COLOR CHANGE

Model Number REORDER CODE 1112

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2020

Event Type  malfunction  

Event Description

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).

• Brand Name: NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER
• Type of Device: THERMOMETER CLINICAL COLOR CHANGE
• Manufacturer (Section D): MEDTRONIC INDICATORS, INC.
• MDR Report Key: 9558409
• MDR Text Key: 174389573
• Report Number: MW5092047
• Device Sequence Number: 3
• Product Code: FQZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/02/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2022
• Device Model Number: REORDER CODE 1112
• Device Lot Number: 07555
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 98