Devices › Sensor, glucose, invasive, non-adjunctive
Device brand name · Sensor glucose invasive non-adjunctive
Sensor Mmt-5100jc1 Simplera 5pk Ous1: medical device reports filed with FDA
1,107 reports name it, 2024–2026. Manufacturer given most often on reports: Medtronic Minimed. Product code PQF.
- 1,107
- device reports naming the brand
- 0% of all MAUDE reports · about 444 a year
- 713
- reports, 12 months to August 2026
- 347 in the 12 months before
- 99.7%
- classified as malfunction
- 99.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,107 reports that name the brand "Sensor Mmt-5100jc1 Simplera 5pk Ous1" (sensor glucose invasive non-adjunctive), received between January 2024 and August 2026; the manufacturer given most often on reports is Medtronic Minimed. Spellings of one product vary from report to report.
713 reports arrived in the 12 months to August 2026, up 105% from 347 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 malfunction (99.7%) and injury (0.3%); across all sensor, glucose, invasive, non-adjunctive reports (product code PQF) death is recorded in 0% and malfunction in 99.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are wireless communication problem (80.2%), incorrect, inadequate or imprecise result or readings (17.6%) and calibration problem (4.2%). The patient problems coded most often are hemorrhage/blood loss/bleeding, hypoglycemia and hyperglycemia. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 325,941 reports carrying product code PQF. 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 |
|---|---|---|---|
| Wireless communication problema wireless connection problem | 888 | 80.2% | 52.3% |
| Incorrect, inadequate or imprecise result or readings | 195 | 17.6% | 0.9% |
| Calibration problem | 47 | 4.2% | 0.6% |
| Computer software problema software problem | 16 | 1.4% | 0.1% |
| Retraction problem | 16 | 1.4% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 14 | 1.3% | 1.3% |
| Breakthe device broke | 7 | 0.6% | 0.3% |
| Delivered as unsterile product | 6 | 0.5% | 0% |
| Material twisted/bent | 3 | 0.3% | 0% |
| Packaging problem | 3 | 0.3% | 0% |
| Manufacturing, packaging or shipping problem | 2 | 0.2% | 0% |
| Unexpected therapeutic results | 2 | 0.2% | 0.1% |
| Activation problem | 1 | 0.1% | 0% |
| Difficult to insertthe device was hard to insert | 1 | 0.1% | 0% |
| Failure to fire | 1 | 0.1% | 0% |
| Loss of or failure to bond | 1 | 0.1% | 0% |
| Material integrity problema problem with the device material | 1 | 0.1% | 0% |
| Patient device interaction problem | 1 | 0.1% | 0% |
| Physical resistance/sticking | 1 | 0.1% | 0% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 25 | 2.3% |
| Hypoglycemialow blood sugar | 19 | 1.7% |
| Hyperglycemiahigh blood sugar | 12 | 1.1% |
| Needle stick/puncture | 2 | 0.2% |
| Bruise/contusion | 1 | 0.1% |
| Convulsion, clonic | 1 | 0.1% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
| Respiratory tract infectiona respiratory infection | 1 | 0.1% |
| Skin inflammation/ irritation | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sensor Mmt-5100jc1 Simplera 5pk Ous1 | Product code PQF | All MAUDE reports |
|---|---|---|---|
| Reports | 1,107 | 325,941 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.3% | 0.7% | 36.2% |
| Classified as malfunction | 99.7% | 99.3% | 62.3% |
| Filed by the manufacturer | 100% | 100% | 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 PQF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dexcom G5 Mobile Continuous Glucose Monitoring System | 332,492 | 6 | 0% |
| Transmitter Mmt-7841zn Gst5g Us | 42,013 | 14,186 | 0% |
| Transmitter Mmt-7841zw Gst5g Ous | 31,572 | 12,351 | 0% |
| Sensor Mmt-5120c Instinct 780 5pk Ous 1 | 2,942 | 1,681 | 0% |
| Sensor Mmt-5120d1 Instinct 780 1pk Ous 1 | 2,830 | 1,753 | 0% |
| Transmitter Mmt-7841qzw Gst5g Ous Lckout | 1,632 | 187 | 0% |
| Sensor Mmt-5100jd1 Simplera 1pk Ous1 | 1,356 | 775 | 0% |
| Sensor Mmt-5120d2 Instinct 780 1pk Ous 2 | 1,787 | 1,062 | 0% |
| Dexcom G6 Continuous Glucose Monitoring System | 1,339,562 | 61,710 | 0% |
| Dexcom G5 Mobile Continuous Glucose Monitoring | 490 | 0 | 0% |
| Sensor Mmt-5100jd2 Simplera 1pk Ous2 | 369 | 239 | 0% |
| Sensor Mmt-5100jd3 Simplera 1pk Ous3 | 322 | 196 | 0% |
| SFTWR MMT-8400 CGM Module iOS | 310 | 137 | 0% |
| Xmtr Kit Mmt-7840w1 Grdn 4 9l W | 293 | 180 | 0% |
| Sensor Mmt-5120c2 Instinct 780 5pk Ous 2 | 340 | 133 | 0% |
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 Sensor Mmt-5100jc1 Simplera 5pk Ous1 reports
How many FDA reports name Sensor Mmt-5100jc1 Simplera 5pk Ous1?
1,107 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 713 in the latest 12 months.
What kinds of events are reported?
malfunction (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
wireless communication problem (80.2%), incorrect, inadequate or imprecise result or readings (17.6%), calibration problem (4.2%), computer software problem (1.4%) and retraction problem (1.4%). 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 Sensor Mmt-5100jc1 Simplera 5pk Ous1 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.