MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE; BLOOD GLUCOSE MONITORING SYSTEM

Catalog Number 11001-1

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Hyperglycemia (1905)

Event Date 10/18/2014

Event Type  malfunction  

Event Description

Customer reported the freestyle meter was providing low readings when used with freestyle test strips.The customer reported receiving readings of 108 mg/dl and 232 mg/dl, which were lower than readings of 149 mg/dl and 288 mg/dl obtained on a competitor brand meter.There was no death, serious injury or mistreatment associated with this event.

Manufacturer Narrative

The freestyle system that is referenced in this mdr is 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.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 700
• Manufacturer Contact: meg manager ; 1360 south loop road; alameda, CA 94502-7001 ; 5102392615
• MDR Report Key: 4241717
• MDR Text Key: 21446082
• Report Number: 2954323-2014-01102
• 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: 10/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: 11001-1
• Device Lot Number: 1379132
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: ADC FA1002-2014
• Patient Sequence Number: 1