MAUDE Adverse Event Report: DIGITAL THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 74-362

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2018

Event Type  malfunction  

Event Description

The digital thermometer we have been using is not accurate.We suspected it was reading low, and after purchasing a new thermometer, found a difference of one full degree fahrenheit.The instructions that came with the thermometer specify that it should be accurate to +/- 0.2 degrees.That one degree of inaccuracy could have serious implications for a newborn or immunocompromised pt.(b)(6).

• Brand Name: DIGITAL THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• MDR Report Key: 8009373
• MDR Text Key: 125430597
• Report Number: MW5080865
• 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: Other
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 74-362
• Device Lot Number: 5100041215
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1