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

Model Number 70805-70

Device Problem Low Readings (2460)

Patient Problem Convulsion/Seizure (4406)

Event Date 10/25/2022

Event Type  Injury  

Event Description

A caller reported a low reading with the adc meter, which was lower than customer felt.The caller reported a meter result of 55 mg/dl and customer reportedly had seizure due to this issue.Paramedics were called but reportedly did not provide treatment.No further details were 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported a low reading with the adc meter, which was lower than customer felt.The caller reported a meter result of 55 mg/dl and customer reportedly had seizure due to this issue.Paramedics were called but reportedly did not provide treatment.No further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the freestyle lite meter and freestyle strips were reviewed and the dhrs showed the freestyle lite meter and freestyle strips 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.

Event Description

A caller reported a low reading with the adc meter, which was lower than customer felt.The caller reported a meter result of 55 mg/dl and customer reportedly had seizure due to this issue.Paramedics were called but reportedly did not provide treatment.No further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Meter (b)(6) has been returned and investigated with retained strip.Visual inspection was performed on returned meter.No issues were observed.Meter powered on with button depression and strip insertion.Low and high control solution testing was performed and test was satisfactory.Blank screen was not observed.The complaint was 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: 15794101
• MDR Text Key: 303620017
• Report Number: 2954323-2022-41663
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00699073708274
• UDI-Public: 00699073708274
• 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,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 70805-70
• Device Catalogue Number: 70827
• Device Lot Number: 1171109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White