MAUDE Adverse Event Report: FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM

Catalog Number 11001-1

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

Patient Problems Fatigue (1849); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Dizziness (2194)

Event Date 03/22/2014

Event Type  Injury  

Event Description

Caller (customer's daughter) reported the customer was unable to test due to her adc blood glucose meter turning on with button press but not with test strip insertion.Caller further reported the customer experienced symptoms described as "light headedness, tired, (and) dizzy" and reported the customer visited a health professional.Customer was diagnosed with hypertension and hyperglycemia and was administered a shot; however the caller could not specify the type of shot administered.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.It should be noted that during the course of troubleshooting it was identified the customer was using expired test strips to test.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

The meter was returned and investigated with retained test strips.Meter powered on with button depression and test strip insertion.A power issue with strip port was not observed.The complaint is not confirmed.

• Brand Name: FREESTYLE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• MDR Report Key: 3745477
• MDR Text Key: 4221013
• Report Number: 2954323-2014-00367
• 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,Followup
• Report Date: 03/22/2014

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: Other
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 11001-1
• Device Lot Number: 1177317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2006
• 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: 71 YR