MAUDE Adverse Event Report: ONE TOUCH ULTRA MINI TEST STRIPS

Lot Number 3606095

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2014

Event Type  Injury  

Event Description

I am diabetic and use the one touch ultra mini to test my blood.For the past three weeks my numbers have been higher then normal.Just this morning i tested three times and had three different results.The numbers were 142, 113 and 154.Something is going on with the strips.I can't change them because my insurance company only allows one touch.Dose or amount: test 3 times a day.Frequency: three times daily.Dates of use: (b)(6) 2014.Diagnosis or reason for use: test blood sugar levels.

• Brand Name: ONE TOUCH ULTRA MINI TEST STRIPS
• Type of Device: ONE TOUCH ULTRA MINI TEST STRIPS
• MDR Report Key: 3820106
• MDR Text Key: 4503171
• Report Number: MW5036125
• Device Sequence Number: 1
• Product Code: CGA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/13/2014

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: Other
• Device Expiration Date: 09/30/2015
• Device Lot Number: 3606095
• Other Device ID Number: 106-142
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 55 YR
• Patient Weight: 61