MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 70914-70

Device Problem High Readings (2459)

Patient Problems Muscle Weakness (1967); Malaise (2359); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 06/29/2022

Event Type  Injury  

Event Description

A complaint was received regarding a higher blood glucose test when testing no adc device compared to an adc meter.As a result, on (b)(6) 2022, the customer experienced feeling weak and tired and had a loss of consciousness and was brought to the hospital where an unknown blood glucose test was obtained on the hcp meter.The customer was treated with an insulin injection by a healthcare professional, and was diagnosed with dka (diabetic ketoacidosis).No further information was provided.There was no report of death or permanent injury 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.At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle strips continue to be safe, effective, and perform as intended in the field.Stability data for freestyle strips was reviewed and showed no anomalies or non-conformance's that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and freestyle strips, no trends were identified that would indicate any product-related issues.Dhrs (device history record) for the freestyle freedom lite meter were reviewed, and the dhrs showed the freestyle freedom lite meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE FREEDOM LITE
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 15042838
• MDR Text Key: 296072253
• Report Number: 2954323-2022-24563
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 70914-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention