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

Model Number 70805-70

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problem Hypoglycemia (1912)

Event Date 12/20/2021

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.Extended investigation 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 did not identify any indication that the product did not meet specification.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A battery/no power issue was reported with the adc blood glucose meter.Customer was unable to test due to the meter not powering on with button press or test strip insertion and as a result, experienced hypoglycemia.Customer self-treated (unspecified) and received unspecified treatment by third-party.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE 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: 13122849
• MDR Text Key: 283079807
• Report Number: 2954323-2021-97431
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 70805-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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