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

Catalog Number 70805-70

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 05/14/2015

Event Type  Injury  

Event Description

Customer's daughter-in-law contacted adc customer service on (b)(6) 2015 to report the customer was having problems with her adc blood glucose meter which prevented her from receiving a reading.At the time of the original call she denied receiving treatment from someone other than herself or self-treating with an injection.Customer called again on (b)(6) 2015 regarding the delivery of her replacement meter and at that time reported that on the day of her original call she "was in bad shape" and "thought (she) might collapse" so she self-administered a glucagon injection.It was further reported a reading of 257 mg/dl was received, but it is unknown when this reading was obtained and on what meter the reading was received.Customer was contacted in follow-up, but declined to provide any additional information.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once additional information is obtained.It should be noted: the test strips the customer was using expired on (b)(6) 2013.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Additional evaluation code - method: the meter was returned and investigated with retained test strips.All results were within the range specification and no errors were observed during control solution testing.No new issues were observed.Returned meter powered on with insertion of test strips and button depression.Did not observe the meter only providing code 01 when the "m" button was pressed.Did not observe the meter changing the code number when pressing the "c" button without a test strip.Additionally, a device history record (dhr) review of the meter was requested.The dhr for meter serial number (b)(4) indicated the device was performing within its performance claims and met the manufacturer's quality specifications prior to its release.

• Brand Name: FREESTYLE FLASH
• 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: 4847983
• MDR Text Key: 21934913
• Report Number: 2954323-2015-00311
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 70805-70
• Device Lot Number: 1171514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2004
• 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