PRODUCT CODE PZE
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
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
18,038Prior 90 days: 838Injury reports
145Source-classified event typeDeath reports
0Reported relationship is unverifiedReporting change
2052.5%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 17,892. 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 LibreLink
Read FDA report 50515061 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
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Read FDA report 50515070 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
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Read FDA report 50515076 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
FreeStyle LibreLink
Read FDA report 50515083 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Device Alarm System
FreeStyle LibreLink
Read FDA report 50515084 ↗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.