MAUDE Adverse Event Report: KAZ USA, 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 an inaccurate reading.The device was reading in the normal range despite the patient having a fever.The false negative reading may have caused delay in medical attention.The consumer was admitted to the hospital, and was released after five days.There were no further complications and the patient is doing well now.

Manufacturer Narrative

Reading#:1, fluke: 97.7 degrees f, irt-3020: 94.3 degrees f; 2, 97.7 degrees f, 94.3 degrees; 3, 97.7 degrees f, 95.4 degrees f.The temperature taken using the calibrated fluke thermometer and the returned irt-3020 were different by up to 3.4 degrees f.These are falling results.The thermometer is being sent to supplier for further evaluation.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike road; southorough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 3777516
• MDR Text Key: 15817950
• Report Number: 1314800-2014-00030
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRT-3020
• Device Catalogue Number: N/A
• Device Lot Number: 26312RAD
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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