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

Catalog Number 11001-1

Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)

Patient Problem Hypoglycemia (1912)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Customer reported that they were receiving high control solution results on their omnipod system while using freestyle test strips.While performing an investigation on the customer's returned freestyle test strips the control solution test results were not within range specification.Whole blood testing was performed using the customer's test strips.Readings of 121 mg/dl, 158 mg/dl and 455 mg/dl were obtained with the returned test strips in comparison to the laboratory reference reading of 42 mg/dl.The results when plotted on a parkes error grid fell into the "d" and "e" zone respectively 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

Further investigation was perfomed using retained test strip samples from the same lot reported by the customer.Control solution testing was performed and all results were within the range specification and no errors were observed.A device history record review was performed and indicated the test strips were performing within their performance claims and met the manufacturer's quality specifications prior to their release.

• 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 ; 5108644391
• MDR Report Key: 4904119
• MDR Text Key: 6070246
• Report Number: 2954323-2015-00347
• 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: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 11001-1
• Device Lot Number: 1454929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2015
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1