inforMED
MalfunctionFQZ

NEXTEMP LATEX-FREE SINGLE-USE CLINICAL THERMOMETER

Received Jan 6, 2020 · Event occurred Jan 2, 2020

Report MW5092047 · MDR key 9558409

Device

Generic name

Thermometer Clinical Color Change

Model number

REORDER CODE 1112

Lot number

07555

Product problems

  • Product Quality Problem

Patient

58 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

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).