TEMPLE TOUCH PRO SENSOR UNIT, NON-INVASIVE CORE TEMP MONT

Additional Manufacturer Narrative

A MEDWATCH WAS RECEIVED FROM A UNKNOWN DEROYAL CUSTOMER STATING, THE TEMPLE TOUCH PRO DEVICE WAS NOT MEASURING THE PATIENT'S TEMPERATURE ACCURATELY. THIS WAS CONFIRMED BY THE PATIENT AND ANOTHER TEMPERATURE DEVICE THAT DIFFERED FROM THE TEMPLE TOUCH PRO." NO INITIAL REPORTING INFORMATION INCLUDING NAME OR FACILITY WAS GIVEN. DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE. BECAUSE THIS IS A PURCHASED PRODUCT, DEROYAL DID NOT HAVE SPECIFICATIONS OR RISK ANALYSIS TO REVIEW. INVENTORY WAS UNABLE TO BE CHECKED AS NO INVENTORY WAS PRESENT. DEROYAL ALSO WORKED WITH CUSTOMERS TO RE-TRAINED ON USE OF THE TTP AND HOW TO APPLY TO GET ACCURATE READINGS. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER. BECAUSE THE PRODUCT WAS UNAVAILABLE FOR RETURN, THE SUPPLIER WAS UNABLE TO PERFORM AN ENTIRE INVESTIGATION. ROOT CAUSE: BECAUSE NO SAMPLE WAS AVAILABLE FOR RETURN AND NO ISSUES COULD BE FOUND WITHIN THE INVESTIGATION, NO ROOT CAUSE WAS ABLE TO BE DETERMINED. CORRECTIVE OR PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A MEDWATCH WAS RECEIVED FROM A UNKNOWN DEROYAL CUSTOMER STATING, THE TEMPLE TOUCH PRO DEVICE WAS NOT MEASURING THE PATIENT'S TEMPERATURE ACCURATELY. THIS WAS CONFIRMED BY THE PATIENT AND ANOTHER TEMPERATURE DEVICE THAT DIFFERED FROM THE TEMPLE TOUCH PRO." NO INITIAL REPORTING INFORMATION INCLUDING NAME OR FACILITY WAS GIVEN. DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A USER FACILITY REPORTED, "THE TEMPLE TOUCH PRO DEVICE WAS NOT MEASURING THE PATIENT'S TEMPERATURE ACCURATELY. THIS WAS CONFIRMED BY THE PATIENT AND ANOTHER TEMPERATURE DEVICE THAT DIFFERED FROM THE TEMPLE TOUCH PRO."