MAUDE Adverse Event Report: FREESTYLE FLASH; BLOOD GLUCOSE MONITORING SYSTEM

Catalog Number 17001

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Hyperglycemia (1905); Dizziness (2194)

Event Date 01/26/2014

Event Type  Injury  

Event Description

Customer reported she was unable to test due to her adc blood glucose meter not powering on with button press or test strip insertion even after battery replacement.Customer further reported that on an unknown date, she experienced dizziness and, because she was "not sure if it's because of her sugar or stress at home", she self-presented to the emergency room.Customer stated her blood glucose was checked and found to be elevated so she was treated with "glometeride" (glimepiride) given fluids to rehydrate her.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.Note: the actual date of the reported medical event is unknown.The date entered is the complaint awareness date.Additionally, the meter serial number is unknown, therefore, the device manufacture date is unknown.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE FLASH
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• MDR Report Key: 3641275
• MDR Text Key: 15180229
• Report Number: 2954323-2014-00118
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2014

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 17001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR