Devices › Pump, infusion, insulin
Device brand name · Insulin infusion pump
H-Tronplus V100 Insulin Infusion Pump: medical device reports filed with FDA
418 reports name it, 2000–2003. Manufacturer given most often on reports: Disetronic Medical Systems. Product code LZG.
- 418
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 81.6% across the product code
- 1.9%
- classified as death, as reported
- 8 reports · not verified by FDA
FDA's MAUDE database holds 418 reports that name the brand "H-Tronplus V100 Insulin Infusion Pump" (insulin infusion pump), received between January 2000 and October 2003; the manufacturer given most often on reports is Disetronic Medical Systems. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (98.1%) and death (1.9%); across all pump, infusion, insulin reports (product code LZG) death is recorded in 0.3% and malfunction in 81.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are other (for use when an appropriate device code cannot be identified) (1.7%), device displays incorrect message (1.4%) and method, improper/incorrect (1.4%). The patient problems coded most often are hyperglycemia, hospitalization required and hypoglycemia. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming H-Tronplus V100 Insulin Infusion Pump was received in the five years to August 2026; the latest was received in October 2003.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 539,975 reports carrying product code LZG. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Other (for use when an appropriate device code cannot be identified) | 7 | 1.7% | 0.1% |
| Device displays incorrect message | 6 | 1.4% | 6.8% |
| Method, improper/incorrect | 6 | 1.4% | 0% |
| Excess flow or over-infusion | 4 | 1% | 0.3% |
| Crackthe device cracked | 3 | 0.7% | 3.8% |
| Device issuea problem with the device | 3 | 0.7% | 0.3% |
| Incorrect software programming calculations | 3 | 0.7% | 0% |
| Air leak | 2 | 0.5% | 0.3% |
| Bent | 2 | 0.5% | 1.4% |
| Breakthe device broke | 2 | 0.5% | 2.9% |
| Improper or incorrect procedure or method | 2 | 0.5% | 1.1% |
| Labelling, instructions for use or training problem | 2 | 0.5% | 0% |
| Replace | 2 | 0.5% | 0.6% |
| Absorption | 1 | 0.2% | 0% |
| Complete blockage | 1 | 0.2% | 0% |
| Component(s), broken | 1 | 0.2% | 0% |
| Component(s), worn | 1 | 0.2% | 0% |
| Contamination | 1 | 0.2% | 0.3% |
| Defective component | 1 | 0.2% | 0.1% |
| Detachment of device component | 1 | 0.2% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hyperglycemiahigh blood sugar | 294 | 70.3% |
| Hospitalization required | 279 | 66.7% |
| Hypoglycemialow blood sugar | 94 | 22.5% |
| Therapy/non-surgical treatment, additional | 47 | 11.2% |
| Other (for use when an appropriate patient code cannot be identified) | 23 | 5.5% |
| Treatment with medication(s) | 22 | 5.3% |
| Vomitingbeing sick | 12 | 2.9% |
| Blood glucose, high | 11 | 2.6% |
| Deaththe patient died; cause not stated by this term | 7 | 1.7% |
| Blood glucose, low | 5 | 1.2% |
| Loss of consciousnesspassing out | 5 | 1.2% |
| Cardiac arrestthe heart stopped | 3 | 0.7% |
| Nauseafeeling sick | 3 | 0.7% |
| Myocardial infarctionheart attack | 2 | 0.5% |
| Overmedicated | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | H-Tronplus V100 Insulin Infusion Pump | Product code LZG | All MAUDE reports |
|---|---|---|---|
| Reports | 418 | 539,975 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 19 | 3 | 9 |
| Classified as injury | 98.1% | 17.8% | 36.2% |
| Classified as malfunction | 0% | 81.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LZG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Onetouchping Glucosemgmtsystem | 98,945 | 0 | 0.1% |
| Omnipod DASH Insulin Management System | 62,646 | 5,563 | 0.1% |
| Tandem T Slim Insulin Delivery System | 55,207 | 0 | 0.1% |
| OmniPod Insulin Pump | 45,272 | 145 | 0.3% |
| Omnipod Insulin Management System | 37,582 | 218 | 0.1% |
| Animas Vibe | 88,703 | 0 | 0% |
| Animas Insulin Infusion Pump | 26,293 | 0 | 0.3% |
| MMT-712 PARADIGM Insulin Pump | 25,781 | 4,138 | 0% |
| Accu-Chek Spirit Combo | 21,252 | 0 | 0.1% |
| t:slim Insulin Delivery System | 19,277 | 30 | 0.1% |
| t:slim X2 Insulin Pump | 31,159 | 86 | 0% |
| Animas Insulin Cartridge | 12,105 | 0 | 0% |
| T Flex Insulin Delivery System | 11,359 | 0 | 0.1% |
| Paradigm Insulin Infusion Pump | 16,324 | 0 | 0.4% |
| Accu-Chek Spirit | 8,826 | 0 | 0.3% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about H-Tronplus V100 Insulin Infusion Pump reports
How many FDA reports name H-Tronplus V100 Insulin Infusion Pump?
418 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (98.1%) and death (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
other (for use when an appropriate device code cannot be identified) (1.7%), device displays incorrect message (1.4%), method, improper/incorrect (1.4%), excess flow or over-infusion (1%) and crack (0.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that H-Tronplus V100 Insulin Infusion Pump was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.