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

Model Number 87-935-000(TH1091)

Device Problem Low Test Results (2458)

Patient Problem Fever (1858)

Event Type  Injury  

Manufacturer Narrative

Query the dmr/dhf file of (b)(4), and the process records the design defects of the problem that does not appear for customer feedback; query the dhr file of (b)(4): investigate the maximum 5 orders for shipments from 2018 to 2019 (involving quantity: (b)(4) pcs), and the temperature measurement in the process is not abnormal, special mining, poor inspection, rework, etc.Problem, the process of determining the production process is relatively stable; after investigating the customer's feedback, according to the experience of historical issues, the suspected product sensor is dirty and the temperature measurement is low; for this customer feedback, the customer needs to follow up the patient status and further feedback the problem information; based on the current survey information, the customer feedback product has no abnormality in the process of the process.It is initially determined that the product sensor is dirty and the temperature measurement is low, but the final conclusion needs to obtain further key information before it can be confirmed.This report was delayed due to the public key and private key is not match, public key needs to be reinstall in the esg account.

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.

• Brand Name: TOPCO
• Type of Device: INFRARED THERMOMETER
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,nanshan; shenzhen, 51810 8; CH 518108
• Manufacturer (Section G): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; no.3 building xilibaimang xush; industrial estate,nanshan; shenzhen, 51810 8; CH 518108
• Manufacturer Contact: mrs ; block a, 5th floor, fuhua tech; no. 9116 beihuan road; shenzhen, 51805-7
• MDR Report Key: 9264703
• MDR Text Key: 184758839
• Report Number: 3005170249-2019-00002
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• PMA/PMN Number: K100488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 87-935-000(TH1091)
• Device Catalogue Number: 87-935-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization