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

Model Number	71938-01
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Abbott diabetes care received a medwatch report which reported the following information pertaining to an abbott diabetes care (adc) device: the customer reported that on occasion, the adc device: "the reader is very old, and it's volume has slipped away, they patient can no longer hear its alarms." adc customer service attempted to contact the customer 3 (three) times to gain additional details regarding this event; follow up attempt was successful.There was no report of adverse event or third-party intervention required due to the reported product issue.Based on the information provided, there was no report of serious injury associated with this event.
Additional Manufacturer Narrative
This complaint was received via user report and has been reported to fda.Extended investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader met specifications prior to release to distribution.Reader (b)(6) was returned and investigated.Visual inspection was performed on the returned reader and no issues were observed.The audio and vibration functions were tested using approved software.Both audio and vibration functions worked properly.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care received a medwatch report which reported the following information pertaining to an abbott diabetes care (adc) device: the customer reported that on occasion, the adc device: "the reader is very old, and it's volume has slipped away, they patient can no longer hear its alarms." adc customer service attempted to contact the customer 3 (three) times to gain additional details regarding this event; follow up attempt was successful.There was no report of adverse event or third-party intervention required due to the reported product issue.Based on the information provided, there was no report of serious injury associated with this event.

• Brand Name: FREESTYLE LIBRE 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: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 21937023
• Report Number: 2954323-2025-15546
• Device Sequence Number: 7893126
• Product Code: PZE
• UDI-Device Identifier: 00357599002008
• UDI-Public: (01)00357599002008(10)01B324D
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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 Model Number: 71938-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2021
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White