MAUDE Adverse Event Report: KAZ, INC. BRAUN; THERMOMETER

Model Number IRT-3020

Device Problem Low Readings (2460)

Patient Problem No Code Available (3191)

Event Date 03/01/2014

Event Type  Other  

Event Description

A consumer reported that his thermometer had given a false negative reading when taking a temperature on their child.The device was reading in the normal range despite the patient having a fever.The child was taken to their physician, where a fever was confirmed.There were no further complications and the patient is doing well now.

Manufacturer Narrative

Using a welch allen black body the irt-3020 was retested.The black body was set to 96.8 degrees fahrenheit and the irt-3020 was set to cal mode.The temperature of the black body was taken and the reading was 95.8 degrees fahrenheit.These are failing results.The thermometer is being sent to supplier for further eval.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer (Section G): KAZ, INC.; one vapor trail; hudson NY 12534
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3780955
• MDR Text Key: 4431738
• Report Number: 1314800-2014-00031
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-3020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other