MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FreeStyle Libre; Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Model Number	71531-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The customer received sensor scan results of 2.10 mg/dl compared to readings of 7.80 mg/dl respectively obtained on a meter and the results, when plotted on a parkes error grid, fall into the c zone, showing the difference in values to be clinically significant.The length of sensor wear was 11 days.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FreeStyle Libre
• Common Device Name: Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 -700
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502--700 ; 4157205405
• MDR Report Key: 25548497
• Report Number: 2954323-2026-136010
• Device Sequence Number: 20230285
• Product Code: PZE
• UDI-Device Identifier: 00357599000196
• UDI-Public: (01)00357599000196(17)260731(10)7630749
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2026
• Device Model Number: 71531-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2025
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Sex: Unknown