MEDLINE

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2026, IT WAS DISCOVERED THAT TWO THERMOMETERS WERE PRODUCING "VARIED" READINGS. THE CUSTOMER REPORTED "GETTING LOTS OF DIFFERENT READINGS" WHEN TAKING THE TEMPERATURE, SEVERAL TIMES ON THE SAME PERSON. THE CUSTOMER REPORTED THERE WAS NO FOLLOW-UP CARE, MEDICAL, AND/OR SURGICAL INTERVENTION OR TREATMENT REQUIRED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. NO MEDICAL INTERVENTION, SERIOUS INJURY, OR FOLLOW-UP CARE HAS BEEN REPORTED. BASED ON THE INFORMATION REVIEWED, THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY, HOWEVER A REPORTABLE MALFUNCTION (A MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR) IS PRESENT. THIS COMPLAINT REQUIRES A MDR SUBMISSION, WHICH HAS BEEN COMPLETED AND DOCUMENTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2026, IT WAS DISCOVERED THAT TWO THERMOMETERS WERE PRODUCING "VARIED" READINGS. THE CUSTOMER REPORTED "GETTING LOTS OF DIFFERENT READINGS" WHEN TAKING THE TEMPERATURE, SEVERAL TIMES ON THE SAME PERSON.