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

Catalog Number 99825-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Sweating (2444)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Customer reported that on (b)(6) 2016 at 1:00 pm she was "shivering, sweating, experiencing dizziness and could not stand up", so she performed a test using her adc blood glucose meter and received a reading of 125 mg/dl.She then self-treated with chocolate milk.Approximately an hour later she retested and received a reading of 106 mg/dl at 2:00.Later, at "15:15 pm" she self-presented to a hospital where she was diagnosed with hypoglycemia and treated with a "glucose injection".No hospital blood glucose result was provided.There was no report of death or permanent injury associated with this event.

• Brand Name: PRECISION XTRA
• 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: 5719057
• MDR Text Key: 47195424
• Report Number: 2954323-2016-02580
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K040814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 99825-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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: 68 YR
• Patient Weight: 33