PRODUCT CODE QLG
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Reporting increase · investigate. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
59,712Prior 90 days: 6,972Injury reports
756Source-classified event typeDeath reports
1Reported relationship is unverifiedReporting change
756.5%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 58,940. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
FreeStyle Libre 2
Read FDA report 50144616 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Incorrect, Inadequate or Imprecise Result or Readings
FreeStyle Libre 2
Read FDA report 50515035 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
FreeStyle Libre 2
Read FDA report 50515040 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
FreeStyle Libre 2
Read FDA report 50515047 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
FreeStyle Libre 2
Read FDA report 50515068 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.