MAUDE Adverse Event Report: LIFESCAN ONE TOUCH VERIOIQ

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 06/26/2017

Event Type  Injury  

Event Description

Awoke with symptoms of severe hypoglycemia.My husband realized and went to get juice.I was shaking so badly he was unable to get enough juice in and called 911.When emt arrived my sugar was checked on the one touch verioiq which showed 221.Paramedics checked on their machines one minute later which showed 80 - which was also much higher than what it was.Because of the high sugar result they did not treat me.Instead of treating me with dextrose they brought me unconscious out of the home.En route to the hospital sugar was checked again and was 23.

• Brand Name: ONE TOUCH VERIOIQ
• Type of Device: ONE TOUCH VERIOIQ
• Manufacturer (Section D): LIFESCAN
• MDR Report Key: 6676687
• MDR Text Key: 78908979
• Report Number: MW5070705
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 63