PSUR Report — FDA Post-Market Data for Your PSUR

Product Code: OZP FDA class 3

Automated Insulin Dosing Device System, Single Hormonal Control

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Adverse events in period

277,933

0% vs. prior period (279,316)

Deaths reported

282

Recalls in period

8

Class I enforcement

3

Adverse events per month

2024-07 – 2026-06

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Events by type

Period vs. prior period

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Event type

Period

Prior

Death

282

552

Injury

33,384

29,094

Malfunction

244,266

249,670

Other

1

0

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Most reported coded problems

Top 15

Product problems

Count

Obstruction of Flow

59,852

Break

38,946

Power Problem

29,533

Incorrect, Inadequate or Imprecise Result or Readings

27,828

Battery Problem

22,916

Key or Button Unresponsive/not Working

22,369

Adverse Event Without Identified Device or Use Problem

21,158

Appropriate Device Problem Term/Code Not Available

17,509

Material Integrity Problem

16,458

Mechanical Problem

15,443

No Display/Image

14,017

Insufficient Flow or Under Infusion

10,613

Wireless Communication Problem

9,582

Fracture

9,564

Unexpected Therapeutic Results

8,616

Patient problems

Count

No Clinical Signs, Symptoms or Conditions

207,458

Hyperglycemia

48,998

Hypoglycemia

19,383

Hemorrhage/Blood Loss/Bleeding

3,568

Elevated ketones/Diabetic Ketoacidosis

3,257

Malaise

1,808

Insufficient Information

1,483

Fatigue

964

Vomiting

956

Loss of consciousness

922

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

728

Pain

718

Headache

701

Confusion/ Disorientation

658

Nausea

491

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Recalls in period

8 total

FDA enforcement classification: Class I: 3 Class II: 27

Date

Recalling firm

Status

Reason

2026-02-13

Medtronic MiniMed, Inc.

Open, Classified

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

2026-02-13

Medtronic MiniMed, Inc.

Open, Classified

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

2025-11-02

Medtronic MiniMed, Inc.

Open, Classified

A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

2025-01-31

Medtronic MiniMed, Inc.

Open, Classified

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

2025-01-31

Medtronic MiniMed, Inc.

Open, Classified

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

2025-01-31

Medtronic MiniMed, Inc.

Open, Classified

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

2025-01-31

Medtronic MiniMed, Inc.

Open, Classified

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

2024-07-31

Medtronic MiniMed, Inc.

Open, Classified

Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

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Adverse events by year

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Methodology & data provenance

For your PSUR appendix

Search protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code OZP, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).

Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.

Generated: 2026-07-06 00:16 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.

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PSUR database searches, explained

Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").

Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.

Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.