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 Problems Hyperglycemia (1905); Vomiting (2144); Weakness (2145); Diabetic Ketoacidosis (2364)

Event Date 05/20/2015

Event Type  Injury  

Manufacturer Narrative

As product was not returned and the test strip lot reported with this complaint is unknown, a device history review (dhr) of the meter was requested.The dhr for meter serial number (b)(4) indicated the device was performing within its performance claimsand met the manufacturer's quality specifications prior to its release.

Event Description

Caller (customer's wife) reported that on (b)(6) 2015 at approximately 10:00 a.M., she came home from work and found her husband in the bathroom "vomiting and feeling weak", stating he was unable to test using his adc blood glucose meter due to an unspecified meter issue.Caller treated the customer with orange juice and then transported him to a local hospital where a blood glucose result of 1000 mg/dl was obtained.Customer was diagnosed with diabetic ketoacidosis (dka) and was administered insulin via intravenous infusion.Customer was still in the hospital at the time of the call.There was no report of death or permanent impairment associated with this event.

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.

• 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: 4839207
• MDR Text Key: 14234460
• Report Number: 2954323-2015-00307
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092602
• 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: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 11001-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2003
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 91