MAUDE Adverse Event Report: EXERGEN CORPORATION TAT-2000C/SMARTGLOW TEMPORAL SCANNER; THERMOMETER, ELECTRONIC, CLINICAL

Lot Number 50072

Device Problems Low Readings (2460); Device Sensing Problem (2917)

Patient Problem Fever (1858)

Event Date 06/05/2022

Event Type  malfunction  

Event Description

We used a model "tat-2000c smartglow temporalscanner" made by exergen to take the temperature of our 2 month old child.The device kept registering a temperature of 97.1 - 98.0 over two days.On day two we got a rectal thermometer and took the babies temperature and it was registering 100.5 and within the same minute the temporalscanner registered 97.1.100.4 is when new borns are supposed to go to the hospital.Because of this device failing to read properly, we were unaware our child should be going to the hospital instead of bed and put our child at risk of serious injury or death.Fda safety report id # (b)(4).

• Brand Name: TAT-2000C/SMARTGLOW TEMPORAL SCANNER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): EXERGEN CORPORATION
• MDR Report Key: 14732225
• MDR Text Key: 294506625
• Report Number: MW5110375
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 50072
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 5 KG
• Patient Race: White