inforMED
MalfunctionFLL

MEDLINE

Received May 3, 2026 · Event occurred Mar 23, 2026

Report 1417592-2026-00731 · MDR key 25062945

Device

Generic name

Thermometer,temple,6-10 Second

Catalog number

MDS9698L

Product problems

  • Image Display Error/Artifact

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

CUSTOMER REPORTED, "I HAVE A PROBLEM SO FAR WITH 5 OF THE 8 THERMOMETERS WE ORDERED ON PO (B)(4) INSTANT READ DIGITAL TEMPLE THERMOMETER, 6 TO 10 SECONDS. WHEN YOU TURN THEM ON, THEY ERROR OUT AS ER.1. WE HAVE TRIED IN THE PREOP AREA, OFFICE AREA AND IN MY AREA THAT IS A LITTLE WARMER AT TIMES, THEY STILL ERROR OUT. THERE ARE 5 OF THE 8 WE CAN NOT USE." DUE DILIGENCE HAS BEEN COMPLETED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

CUSTOMER REPORTED, "I HAVE A PROBLEM SO FAR WITH 5 OF THE 8 THERMOMETERS WE ORDERED ON PO (B)(4) INSTANT READ DIGITAL TEMPLE THERMOMETER, 6 TO 10 SECONDS. WHEN YOU TURN THEM ON, THEY ERROR OUT AS ER.1. WE HAVE TRIED IN THE PREOP AREA, OFFICE AREA AND IN MY AREA THAT IS A LITTLE WARMER AT TIMES, THEY STILL ERROR OUT. THERE ARE 5 OF THE 8 WE CAN NOT USE."