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

Catalog Number 11001-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Dizziness (2194)

Event Date 08/06/2016

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for an investigation.A follow-up report will be filed once additional information is obtained.The manufacturing date is unknown.The date listed in device manufacture date is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller (customer's mother, customer is an (b)(6)) reported that the test would not start after applying a sample to an adc freestyle test strip used with the built-in freestyle test strip port of her omnipod (insulet).The caller reported that around 12:30 pm on (b)(6) 2016 her daughter was playing softball when she became dizzy and lightheaded.The caller attempted to perform a blood glucose test, but could not obtain a result.The caller tried several test strips, but was unable to obtain a reading.It was reported that the customer was unable to self-treat due to her symptoms and shortly after 12:30 pm the caller treated her daughter with three glucose tablets and some juice.There was no report of death or permanent injury associated with this event.

• 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: 5919442
• MDR Text Key: 53663893
• Report Number: 2954323-2016-04480
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 11001-1
• Device Lot Number: 1530106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 59