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

Model Number FHT1000

Device Problem Low Readings (2460)

Patient Problem Seizures (2063)

Event Date 05/01/2015

Event Type  Injury  

Event Description

The consumer reported their thermometer was giving false negative readings on their child.The device allegedly was reading 7-8 degrees lower than the childs actual temperature.The child suffered a seizure and was treated at a hospital, where it was confirmed that they had a fever.The child was treated at the hospital for 3 to 4 hours, and was then released.Kaz usa, inc.Has requested that the product be returned to our company for testing.

Manufacturer Narrative

This is above the allowable tolerance.The sample was cleaned again, and then was sent to the supplier for further evaluation.Supplier test lab observation and data: supplier test date: 08/07/2015 root cause analysis: the returned thermometer was inspected and tested by the supplier after a cleaning with a q-tip and ipa was performed.Three accuracy tests were performed at each accuracy test point.The results of the accuracy testing are shown below: water bath set point 95.0 degrees f; 94.6 f, 94.7 f, 94.6 f(all pass); water bath set point 98.6 degrees f: 98.3 f, 98.4 f, 98.3 f (all pass).Water bath set point 105.8 degrees f: 105.5 f, 105.4 f, 105.5 f (all pass).These results of the accuracy test (post cleaning) show that the thermometer meets accuracy acceptance criteria of 0.4 degrees f.These are passing results.The cause of the false negative reading was a dirty lens.The instructions for proper use state that the thermometer should be cleaned in between uses, as necessary.

• Brand Name: BRAUN
• Type of Device: THERMOMETER
• Manufacturer (Section D): KAZ USA, INC.; southbourough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4909649
• MDR Text Key: 6067808
• Report Number: 1314800-2015-00053
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FHT1000
• Device Lot Number: 08013ONB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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; Other; Required Intervention
• Patient Age: 1 YR