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

Model Number 70805-70

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problem Hypoglycemia (1912)

Event Date 09/27/2022

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 there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle freedom lite meter and freestyle freedom lite strips 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.The date the incident occurred is unknown.The date entered 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 customer reported that their adc device did not start after the blood sample was applied and as a result, the customer was unable to obtain readings.The customer further reported that their blood glucose was getting low, and felt weak.The customer called the ambulance and they were administered glucose for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that their adc device did not start after the blood sample was applied and as a result, the customer was unable to obtain readings.The customer further reported that their blood glucose was getting low, and felt weak.The customer called the ambulance and they were administered glucose for the diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Meter (b)(6) has been returned and investigated.Visual inspection has been performed on the returned meter and no issues were observed.The returned meter was investigated with retained test strips.Meter powered on with button depression and test strip insertion.Control solution testing has been performed and the test started after the sample was applied.Therefore this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• 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: 15624458
• MDR Text Key: 301911086
• Report Number: 2954323-2022-38403
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00699073708052
• UDI-Public: 00699073708052
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 70805-70
• Device Catalogue Number: 70805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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