Libre App 78745-01Recalls & reported problems
Abbott Diabetes Care Inc · Libre Android App US · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00357599840006), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Application Program Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K233537); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Application Program Problem1
Patient problems
- Confusion/ Disorientation1
- Hypoglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2025Application Program Problem; Application Program Problem
AN INCOMPATIBLE OPERATING SYSTEM/DEVICE ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH PIXEL CHROME PRO WITH ANDROID OPERATING SYSTEM VERSION 16. AS A RESULT, THE CUSTOMER WAS UNABLE TO "REGISTER THE SENSOR" AND RECEIVE LOW GLUCOSE ALARMS AND SUBSEQUENTLY RECEIVED A SENSOR ERROR MESSAGE. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS LETHARGY, "COMPLETE SATURATION", AND CONFUSION. AFTER THE DEVICE STARTED WORKING, THE CUSTOMER OBTAINED A READING OF 42 MG/DL ON THE ADC DEVICE AND RECEIVED THIRD-PARTY ADMINISTRATION OF COKE AND GLUCOSE TABLETS FOR TREATMENT. THE CUSTOMER DID NOT NOTICE A TREND ARROW ON THE DEVICE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Patient problems: Confusion/ Disorientation; Hypoglycemia
MAUDE report 23044178 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K233537. One submission often covers many models, so check the product and lot details in each record.
- Z-1022-2026 · Nov 24, 2025 · Open, ClassifiedFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst
- Z-1021-2026 · Nov 24, 2025 · Open, ClassifiedFreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring Syst
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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