MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE SENSOR 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71940-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Skin Infection (4544)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse skin reaction was reported with wear of the adc device.Customer experienced a sensor site infection that ¿went to the system and blood sugar went up to over 200¿.The customer had contact with an hcp who prescribed antibiotics for treatment.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.The sensor lot expired as of 31-mar-22, therefore, sensor testing not applicable in this case.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.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.
Additional Manufacturer Narrative
The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.The sensor kit associated with this complaint has an expiration date of 31 mar 2022.The reported complaint occurred on 04 oct 2022, which confirms the usage of the device beyond the useful life of the device.Additional investigation activities are not required as the device met specification when it was released and throughout its lifespan.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.This serves as a correction report.Section h6 and h10 have been updated to reflect the correct investigation results.
Event or Problem Description
An adverse skin reaction was reported with wear of the adc device.Customer experienced a sensor site infection that ¿went to the system and blood sugar went up to over 200¿.The customer had contact with an hcp who prescribed antibiotics for treatment.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE SENSOR 14 DAY
• Common Device Name: FLASH 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: 16477139
• Report Number: 2954323-2023-08792
• Device Sequence Number: 7250113
• Product Code: PZE
• UDI-Device Identifier: 00357599001025
• UDI-Public: 00357599001025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160030
• 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): 03/08/2024

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: 03/31/2022
• Device Model Number: 71940-01
• Device Catalogue Number: 71939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 75 YR
• Patient Sex: Male