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

Model Number 98814-65

Device Problem Calibration Problem (2890)

Patient Problems Hyperglycemia (1905); Weakness (2145); Dizziness (2194)

Event Date 01/21/2017

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 device manufacturer date for the reported meter serial number is unknown.All pertinent information available to abbott diabetes care has been submitted.

Event Description

On (b)(6) 2017 a customer reported that her adc blood glucose meter had a calibration issue and would not provide a reading when a test strip was inserted.On (b)(6), the customer called back to inquire about the delivery status of the replacement meter that had not arrived.She also reported experiencing a medical event as a result of being unable to test her blood glucose.The customer reported that on (b)(6), she felt ¿dizzy and weak¿, and her husband took her to the emergency room.At the hospital emergency room, the customer¿s blood glucose was measured at 392 mg/dl and she was diagnosed with hyperglycemia.The customer was treated with ¿insulin and serum intravenously¿.

Manufacturer Narrative

No product was returned for this complaint and a valid serial/lot number was not provided.Reviews of all dhrs for all strips within expiration at the time of complaint was performed and the dhr review showed no there were no deviations from the validated manufacturing process.

Event Description

On (b)(6) 2017 a customer reported that her adc blood glucose meter had a calibration issue and would not provide a reading when a test strip was inserted.On (b)(6) the customer called back to inquire about the delivery status of the replacement meter that had not arrived.She also reported experiencing a medical event as a result of being unable to test her blood glucose.The customer reported that on (b)(6) she felt ¿dizzy and weak¿, and her husband took her to the emergency room.At the hospital emergency room, the customer¿s blood glucose was measured at 392 mg/dl and she was diagnosed with hyperglycemia.The customer was treated with ¿insulin and serum intravenously¿.

• 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 (Section G): ABBOTT DIABETES CARE INC.; 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: 6344465
• MDR Text Key: 67801056
• Report Number: 2954323-2017-01295
• 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,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 98814-65
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2017
• Is the Device Single Use?: No
• 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: 41 YR
• Patient Weight: 72