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

Model Number	70920-71
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported meter (b)(4) has been returned and investigated with returned test strips 1144536.Visual inspection has been performed and no issues were observed.Meter powered on with button depression and strip insertion.All results were within range specification and no errors were observed during control solution testing.No malfunction or product deficiency was identified.The complaint is not confirmed.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 strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.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.Retain testing was performed for freestyle strips and all units performed in specification and passed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer's wife reported that her husband received a reading of 179 mg/dl at 6:35 p.M.On his adc blood glucose meter and was treated with 65 units of insulin at 7 p.M.Before dinner.After dinner, customer fell asleep, was unresponsive and experienced symptoms described as "jaw locked, eyes half open, clammy skin" and a loss of consciousness and a reading of 65 mg/dl was obtained at 7:20 p.M.On an unspecified meter.Paramedics was called and a reading of 23 mg/dl was obtained on the hcp meter and he was treated with a glucose shot via iv.After 5 minutes, customer woke up and was able to eat peanut butter, jelly sandwich and a reading of 180 mg/dl on an unspecified meter.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: 11745798
• Report Number: 2954323-2021-67884
• Device Sequence Number: 14509604
• Product Code: NBW
• UDI-Device Identifier: 00699073710260
• UDI-Public: 00699073710260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 01/31/2023
• Device Model Number: 70920-71
• Device Catalogue Number: 71026
• Device Lot Number: 1144536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/29/2021
• 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: 71 YR
• Patient Weight: 86