MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ORAL THERMOMETER

Catalog Number MDS9950

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Fever (1858)

Event Date 03/14/2015

Event Type  Injury  

Event Description

The facility reported incorrect readings resulted in additional diagnostic testing, iv antibiotics and an extended hospital stay.

Manufacturer Narrative

The facility reported the thermometer reading indicated a temperature greater than 100 degrees repeatedly which resulted in diagnostic testing being ordered, iv antibiotics administered and the hospital stay extended.They later determined the elevated temperature reading was not correct.No sample was returned for eval.We have had no response to multiple requests asking for additional info pertaining to this report.We have not confirmed the readings were inaccurate of identified a root cause.The existence of other clinical symptoms and/or contributing factors is not known.However, due to the reported incident and in an abundance of caution, this medwatch is being filed.

• Brand Name: ORAL THERMOMETER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4906183
• MDR Text Key: 6031926
• Report Number: 1417592-2015-00051
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDS9950
• Device Lot Number: 14269326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention