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

Model Number	70920-71
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/18/2021
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 date of event is unknown.The date entered is the date reported as "2weeks ago." all pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving an error message on the display of his adc blood glucose meter after blood sample was applied on the strip and was therefore unable to test.Customer further reported that he experienced a medical event and was rushed to hospital as his glucose levels were 585 mg/dl on an unspecified meter.No further information was provided as customer refused to continue troubleshooting.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported meter (b)(6) and test strips have been returned and investigated.Visual inspection has been performed and contamination on the returned strips was observed.The meter was powered on with a button and with strip insertion.Meter advanced to the apply sample screen.Control solution testing with known good strips has been performed and no issues were observed.All results were within range specification.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving an error message on the display of his adc blood glucose meter after blood sample was applied on the strip and was therefore unable to test.Customer further reported that he experienced a medical event and was rushed to hospital as his glucose levels were 585 mg/dl on an unspecified meter.No further information was provided as customer refused to continue troubleshooting.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: 12050077
• Report Number: 2954323-2021-73451
• Device Sequence Number: 11824778
• 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,Followup
• Report Date (Section B): 10/04/2021

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: 11/30/2022
• Device Model Number: 70920-71
• Device Catalogue Number: 71026
• Device Lot Number: 1142090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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: 89 YR
• Patient Weight: 100