MAUDE Adverse Event Report: FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM

Catalog Number 11001-1

Device Problem Output Problem (3005)

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

Event Date 05/25/2014

Event Type  malfunction  

Event Description

Customer reported having an issue with her readings on her omnipod system while using unspecified freestyle test strips.There was no report of death, serious injury or mistreatment associated with this event.

Manufacturer Narrative

The freestyle test strip lot that is referenced in this mdr, although unknown, may be associated with an on-going recall.The fda was informed of the field action per 21cfr806 (recall number 2954323-02/07/14-001-r) and affected consignees were notified by letter beginning february 19, 2014.Adc has identified that all non-applied voltage legacy blood glucose meters (0mv) may produce erroneously low blood glucose readings in the parkes error grid c or d zone that could potentially affect clinical outcome when used in conjunction with freestyle test strip lot within expiry.This issue only occurs when freestyle or freestyle lite blood glucose test strips are used with freestyle, freestyle flash blood glucose meters and the freestyle blood glucose meter built into the omnipod insulin management system and freestyle navigator.Note: the test strip lot number is unknown; therefore, the device manufacturer date is unknown.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• MDR Report Key: 3887051
• MDR Text Key: 4678726
• Report Number: 2954323-2014-00697
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11001-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ADC FA1002-2014
• Patient Sequence Number: 1