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

Model Number	70914-70
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Confusion/ Disorientation (2553)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The exact date that the incident occurred is unknown.The date entered in section b is based on the report of "4th or 5th of (b)(6) 2021".During the course of troubleshooting it was identified the customer was using expired test strips (nov 2018) to test.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported he was unable to test his blood glucose due to an unspecified error message received on the adc blood glucose meter.The customer experienced symptoms of dizziness, disorientation, and could not walk, and was incapable of self-treating.The customer had contact with a healthcare professional who diagnosed him with hypoglycemia and glucose was administered intravenously as treatment.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
A customer reported he was unable to test his blood glucose due to an unspecified error message received on the adc blood glucose meter.The customer experienced symptoms of dizziness, disorientation, and could not walk, and was incapable of self-treating.The customer had contact with a healthcare professional who diagnosed him with hypoglycemia and glucose was administered intravenously as treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
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 (device history record) for the freestyle freedom lite meter were reviewed and the dhrs showed the freestyle freedom lite meter passed all tests prior to release.Dhrs for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.The strips expired on 30 nov 18, therefore retain testing is not applicable in this case as retain testing only applies to unexpired product.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

• 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: 11716446
• Report Number: 2954323-2021-67376
• Device Sequence Number: 19660372
• Product Code: NBW
• UDI-Device Identifier: 00699073707925
• UDI-Public: 00699073707925
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/01/2021

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: 11/30/2018
• Device Model Number: 70914-70
• Device Catalogue Number: 70792
• Device Lot Number: 1631306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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: 73 YR
• Patient Weight: 99