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

Model Number IRT-3020

Device Problems False Negative Result (1225); Low Test Results (2458)

Patient Problem Seizures (2063)

Event Date 05/13/2015

Event Type  Other  

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 6.1 degrees lower than the child's actual temperature.The child suffered a seizure and was treated at a hospital, where it was confirmed that they had a fever.

Manufacturer Narrative

The customer's issue can be reproduced and all three readings are to low and out of specification.A second test has been done after having cleaned the lens on the probe-tip and again in calibration mode.Findings: black body setting c celsius; 36.0/ irt-3020 c; 36.0 celsius, black body setting c celsius; 38.5 & irt-3020 c; 38.5.Black body setting c celsius; 41.0 & irt-3020 c; 41.0.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike rd.; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike rd.; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4863452
• MDR Text Key: 5812362
• Report Number: 1314800-2015-00048
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K103097
• 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: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IRT-3020
• Device Lot Number: 34112RAD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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): Hospitalization