PRODUCT CODE QFG
Alternate Controller Enabled Insulin Infusion Pump
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
108,645Prior 90 days: 96,355Injury reports
15,013Source-classified event typeDeath reports
82Reported relationship is unverifiedReporting change
12.8%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 93,508. 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 US System BLE Connect 3.0 mg/dL
Read FDA report 50204214 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Power Problem
iLet Bionic Pancreas
Read FDA report 50515056 ↗Received 2026-08-31 · Injury
Patient problems: Hypoglycemia; Loss of consciousness
Device problems: Insufficient Device Problem Information
iLet Bionic Pancreas
Read FDA report 50515060 ↗Received 2026-08-31 · Injury
Patient problems: Hypoglycemia; Vomiting; Loss of consciousness; Convulsion/Seizure
Device problems: Insufficient Device Problem Information
t:slim X2 Insulin Pump with Control-IQ Technology
Read FDA report 50515356 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Failure to Charge
t:slim X2 Insulin Pump with Control-IQ Technology
Read FDA report 50515357 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Pumping Stopped
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.