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

Model Number 98814-65

Device Problem Calibration Problem (2890)

Patient Problem Sweating (2444)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The date of manufacture is unknown.The date listed, 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 called adc customer service on (b)(6) 2017 and reported a calibration issue with his adc blood glucose meter.Customer called back on (b)(6) 2017 and reported a delivery issue with the replacement products.During the call, customer noted that on (b)(6) 2017 he did not have a meter to check his blood glucose status, but needed to inject insulin as part of his treatment.Customer self-administered an unspecified amount of insulin and then started ¿feeling evil and sweating¿ and then ¿lose knowledge for seconds¿.Paramedics were called and upon arrival received a reading of 40 mg/dl on their meter.Customer was treated on the scene with 500cc of 5% glucose solution via oral route of administration.No additional treatment was required.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: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 6452128
• MDR Text Key: 71458391
• Report Number: 2954323-2017-02604
• Device Sequence Number: 1
• Product Code: NBW
• 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: 04/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 98814-65
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 64