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 No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported receiving erratic readings on their omnipod insulin pump while using freestyle test strips.Customer reported receiving readings of 22 mg/dl and 119 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury or mistreatment associated with this event.

Manufacturer Narrative

Method code: the reported test strips were returned and investigated with a retained meter.The complaint is not confirmed and no new issues were observed.All results were within the range specification and no errors were observed during control solution testing.

• Brand Name: FREESTYLE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: meg manager ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 5674284
• MDR Text Key: 45829399
• Report Number: 2954323-2016-02296
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 11001-1
• Device Lot Number: 1516012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1