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

Model Number	70914-70
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	02/14/2022
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 record) 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 record) 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 the incident occurred is unknown.The date entered in 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 receiving unspecified readings that were erratic on adc device and he experienced a loss of consciousness.Customer was seen by a healthcare provider and a reading of 380 mg/dl was obtained.Customer was diagnosed with hyperglycemia and received unspecified treatment.There was no report of death or permanent impairment 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13759215
• Report Number: 2954323-2022-08315
• Device Sequence Number: 5801103
• Product Code: NBW
• UDI-Device Identifier: 00699073710260
• UDI-Public: 00699073710260
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/14/2022

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: 10/31/2023
• Device Model Number: 70914-70
• Device Catalogue Number: 71026
• Device Lot Number: 1165996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male
• Patient Weight: 100 KG