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

Model Number	70914-70
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Codes	Hyperglycemia (1905); Seizures (2063); Loss of consciousness (2418)
Date of Event	08/01/2020
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 freedom lite meter were reviewed and the dhrs showed the freestyle freedom 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 for freestyle strips 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 exact date that the incident occurred is unknown.The date entered is based on the customer report of "beginning of (b)(6) 2020".All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Caller reported on behalf of the customer that he was unable to test due to his adc blood glucose meter turning on with button press but not with test strip insertion.Customer experienced seizure and loss of consciousness.Paramedics was called and upon their arrival, a reading over 500 mg/dl was obtained on an unspecified meter.Customer was treated with insulin and was transported to hospital.Customer was in icu for 2 weeks where he received unspecified treatment and he was at nursing rehab for a month.Customer was prescribed metformin before he was discharged.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE FREEDOM 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: 10781208
• Report Number: 2954323-2020-09677
• Device Sequence Number: 1047980
• Product Code: NBW
• UDI-Device Identifier: 00699073708229
• UDI-Public: 00699073708229
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/03/2020

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: 03/31/2022
• Device Model Number: 70914-70
• Device Catalogue Number: 70822
• Device Lot Number: 1119709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/03/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 82