PRODUCT CODE OZP
Automated Insulin Dosing Device System, Single Hormonal Control
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Death reports · review source evidence. 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
24,700Prior 90 days: 27,971Injury reports
1,609Source-classified event typeDeath reports
11Reported relationship is unverifiedReporting change
-11.7%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 23,073. 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.
MiniMed 780G OUS System BLE Connect 3.0 mmol/L
Read FDA report 50515431 ↗Received 2026-08-31 · Malfunction
Patient problems: Hyperglycemia; Elevated Ketones/ Diabetic Ketoacidosis
Device problems: Insufficient Flow or Under Infusion
SENSOR MMT-7040C1 GUARDIAN4 5PK OUS 1
Read FDA report 50515461 ↗Received 2026-08-31 · Malfunction
Patient problems: Hypoglycemia
Device problems: Incorrect, Inadequate or Imprecise Result or Readings
MiniMed 780G OUS System BLE Connect 3.0 mmol/L
Read FDA report 50515466 ↗Received 2026-08-31 · Malfunction
Patient problems: Hypoglycemia
Device problems: Excess Flow or Over-Infusion
Pump 1886 780G OUS BLE Pump mg/dL
Read FDA report 50515476 ↗Received 2026-08-31 · Malfunction
Patient problems: Hypoglycemia
Device problems: Excess Flow or Over-Infusion
MiniMed 780G US System BLE Connect 3.0 mg/dL
Read FDA report 50515483 ↗Received 2026-08-31 · Injury
Patient problems: Hypoglycemia
Device problems: Excess Flow or Over-Infusion
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.