Devices › Single use only blood lancet with an integral sharps injury prevention feature
Device brand name · Lancet device
Softclix Lancet Device: medical device reports filed with FDA
3,115 reports name it, 2006–2026. Manufacturer given most often on reports: Roche Diagnostics. Product code FMK.
- 3,115
- device reports naming the brand
- 0% of all MAUDE reports · about 155 a year
- 80
- reports, 12 months to August 2026
- 102 in the 12 months before
- 99.5%
- classified as malfunction
- 93.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
3,115 medical device reports received by FDA name the brand "Softclix Lancet Device" (lancet device); the manufacturer given most often on reports is Roche Diagnostics; received from June 2006 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
80 reports arrived in the 12 months to August 2026, down 22% from 102 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 (99.5%) and injury (0.5%); across all single use only blood lancet with an integral sharps injury prevention feature reports (product code FMK) death is recorded in 0% and malfunction in 93.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are retraction problem (97.8%), replace (9.3%) and needle, unsheathed (2.5%). The patient problems coded most often are needle stick/puncture, other (for use when an appropriate patient code cannot be identified) and aneurysm. 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 14,110 reports carrying product code FMK. 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 |
|---|---|---|---|
| Retraction problem | 3,048 | 97.8% | 86% |
| Replace | 289 | 9.3% | 5.7% |
| Needle, unsheathed | 77 | 2.5% | 1.6% |
| Spring loading mechanism problem | 76 | 2.4% | 1.4% |
| Insufficient device problem information | 43 | 1.4% | 1.3% |
| Other (for use when an appropriate device code cannot be identified) | 29 | 0.9% | 0.6% |
| Incorrect, inadequate or imprecise result or readings | 26 | 0.8% | 0.9% |
| Material protrusion/extrusion | 22 | 0.7% | 0.9% |
| Sticking | 10 | 0.3% | 0.4% |
| Material puncture/hole | 8 | 0.3% | 0.2% |
| Incorrect or inadequate test results | 7 | 0.2% | 0.3% |
| Device issuea problem with the device | 5 | 0.2% | 0.2% |
| Breakthe device broke | 3 | 0.1% | 1% |
| Device contamination with body fluid | 3 | 0.1% | 0.1% |
| Failure to fire | 3 | 0.1% | 0.4% |
| Failure to prime | 3 | 0.1% | 0% |
| Improper or incorrect procedure or method | 3 | 0.1% | 0.2% |
| Device, or device fragments remain in patient | 2 | 0.1% | 0.2% |
| Dislodged | 2 | 0.1% | 0.1% |
| Failure to obtain sample | 2 | 0.1% | 0.1% |
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 |
|---|---|---|
| Needle stick/puncture | 44 | 1.4% |
| Other (for use when an appropriate patient code cannot be identified) | 16 | 0.5% |
| Aneurysm | 10 | 0.3% |
| Treatment with medication(s) | 5 | 0.2% |
| Dural tear | 4 | 0.1% |
| Therapy/non-surgical treatment, additional | 4 | 0.1% |
| Hypoglycemialow blood sugar | 3 | 0.1% |
| Skin inflammation/ irritation | 3 | 0.1% |
| Painpain, site not specified | 2 | 0.1% |
| Abrasion | 1 | 0% |
| Bacterial infectiona bacterial infection | 1 | 0% |
| Blood glucose, low | 1 | 0% |
| Cytomegalovirus (cmv) infection | 1 | 0% |
| Device embedded in tissue or plaque | 1 | 0% |
| Erythemaskin redness | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Softclix Lancet Device | Product code FMK | All MAUDE reports |
|---|---|---|---|
| Reports | 3,115 | 14,110 | 26,136,888 |
| Share of that pool | — | 22.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 5.9% | 36.2% |
| Classified as malfunction | 99.5% | 93.5% | 62.3% |
| Filed by the manufacturer | 100% | 98.2% | 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 FMK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Accu-Chek Multiclix | 6,191 | 0 | 0% |
| Softclix Plus Lancet Device | 1,137 | 0 | 0% |
| Accu-Chek Fastclix | 1,063 | 56 | 0% |
| Softclix Plus Gt Lancet Device | 282 | 0 | 0% |
| Bd Microtainer Contact-Activated Lancet | 220 | 10 | 0% |
| Safe-T-Pro | 152 | 0 | 0% |
| Softclix Lancets | 157 | 6 | 0% |
| Ot Delica Lancing Device | 196 | 0 | 0% |
| EasyTouch | 407 | 42 | 0% |
| Accu-Chek Mobile Test Strips | 3,527 | 0 | 0% |
| Freestyle | 9,490 | 26 | 0.1% |
| One Touch Lancing Device | 169 | 0 | 0% |
| Accu-Chek | 270 | 0 | 0% |
| Accu-Chek Advantage | 1,290 | 0 | 0.5% |
| Freestyle Flash | 19,422 | 0 | 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 Softclix Lancet Device reports
How many FDA reports name Softclix Lancet Device?
3,115 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 80 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
retraction problem (97.8%), replace (9.3%), needle, unsheathed (2.5%), spring loading mechanism problem (2.4%) and insufficient device problem information (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 Softclix Lancet Device 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.