MAUDE Adverse Event Report: EXERGEN CORPORATION TEMPORALSCANNER; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2017

Event Type  malfunction  

Event Description

Temperature taken at 0900 read 101.8.Patient well appearing with low suspicion for infection.A verifying rectal temperature was taken which read 99.1.Several repeat temperatures over the next hour and a half were also off by approximately 2 degrees.The patient had additional blood work done as a result.

• Brand Name: TEMPORALSCANNER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): EXERGEN CORPORATION; 400 pleasant street; watertown MA 02472
• MDR Report Key: 6906778
• MDR Text Key: 87872321
• Report Number: 6906778
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1