MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71953-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194); Loss of consciousness (2418); Convulsion/Seizure (4406)
Date of Event	06/29/2021
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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported an unspecified incorrect readings issue using adc freestyle libre 2 reader.On (b)(6) 2021, as a result, the customer was not feeling well and experienced dizziness, passed out, had a seizure, and a loss of consciousness.The customer regained consciousness and self-treated with unspecified medication and metformin for treatment.Hcp contact was made and provided unspecified medical treatment.No further information was provided.There was no report of death or permanent injury 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 for the libre reader and precision strips were reviewed and the dhrs showed the libre reader and precision strips passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported an unspecified incorrect readings issue using adc freestyle libre 2 reader.On (b)(6) 2021 as a result, the customer was not feeling well and experienced dizziness, passed out, had a seizure, and a loss of consciousness.The customer regained consciousness and self-treated with unspecified medication and metformin for treatment.Hcp contact was made and provided unspecified medical treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 12202884
• Report Number: 2954323-2021-76873
• Device Sequence Number: 4486540
• Product Code: QLG
• UDI-Device Identifier: 00093815715795
• UDI-Public: 00093815715795
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K193371
• 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): 08/10/2021

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: 07/31/2022
• Device Model Number: 71953-01
• Device Catalogue Number: 71579
• Device Lot Number: 4500184668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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