MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO LTD TOPCO; INFRARED THERMOMETER

Model Number 87-935-000

Device Problem Low Test Results (2458)

Patient Problem Fever (1858)

Event Type  Injury  

Event Description

End user stated the unit was reading 97-98 degrees fahrenheit over a couple of days.User experienced a seizure and was rushed to the er where his temperature was measured at 105 degrees fahrenheit.Some time (unknown duration of time) after being released, user was ill and purchased another thermometer, which he took with him when he went to see the doctor.The doctor measured his temperature at 101 degrees fahrenheit, while comparing to the second thermometer, which read a temperature of 98.5 degrees fahrenheit.The sample was not available for evaluation.The end user was not willing to provide any further details or communicate with us any further.The temperature readings of the device is dependent upon proper technique, placement, and is influenced by conditions (e.G.Cleanliness of the sensor, acclamation to room, skin conditions, ear infection or wax build-up).It is unknown if the user or doctor used the device according to instructions.This report was found to be an inadvertent omission during an audit of our records.

• Brand Name: TOPCO
• Type of Device: INFRARED THERMOMETER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO LTD; block a, 5th floor, fuhua bl; no. 9116 b; 9116 beihuan road,, 51805 7; CH 518057
• MDR Report Key: 9142361
• MDR Text Key: 161965358
• Report Number: 1422443-2019-00005
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2019,10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 87-935-000
• Device Catalogue Number: 87-935-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2019
• Distributor Facility Aware Date: 05/07/2019
• Event Location: Other
• Date Report to Manufacturer: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization