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

Model Number 70914-70

Device Problem Failure to Power Up (1476)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.An extended investigation has been conducted which involved a manufacturing review (including 5 years of device history records (dhrs)), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation addresses the customer¿s complaint in this case and did not identify any trend or potential root cause that would indicate that the product is not meeting specifications.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.

Event Description

A customer reported that the adc device did not power on with button press or strip insertion.The customer indicated they experienced a loss of consciousness due to hypoglycemia and was treated with sugar and sweet cake provided by spouse.There was no report of death or permanent injury associated with this event.

• 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: 15905677
• MDR Text Key: 304706273
• Report Number: 2954323-2022-44265
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150531
• 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: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 70914-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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