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

Model Number	70805-70
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional 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.The dhrs (device history review) for the freestyle lite meter were reviewed and the dhrs showed the freestyle lite meter passed all tests prior to release.The dhrs (device history review) for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.Retain testing was performed and all units performed in specification and passed.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 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported being unable to test with her adc blood glucose meter due to the test not starting after the blood sample was applied.Customer was brought to hospital where she was diagnosed with hyperglycemia and was treated with unspecified iv and unspecified prescription medication.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported meter (b)(6) has been returned and investigated with retained test strips.Visual inspection has been performed on the returned meter and no issues were observed.The meter powered on with button and with strip insertion.Control solution testing has been performed and no issues were observed.Test started after sample was applied.All results were within range specification.No malfunction or product deficiency was identified.
Event or Problem Description
Customer reported being unable to test with her adc blood glucose meter due to the test not starting after the blood sample was applied.Customer was brought to hospital where she was diagnosed with hyperglycemia and was treated with unspecified iv and unspecified prescription medication.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LITE
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 10751897
• Report Number: 2954323-2020-08914
• Device Sequence Number: 3317883
• Product Code: NBW
• UDI-Device Identifier: 00699073708229
• UDI-Public: 00699073708229
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: 70805-70
• Device Catalogue Number: 70822
• Device Lot Number: 1094888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 62