Devices › Introducer, syringe needle
Device brand name · Spring loaded insertion device
Accu-Chek Linkassist: medical device reports filed with FDA
383 reports name it, 2012–2024. Manufacturer given most often on reports: Roche Diabetes Care. Product code KZH.
- 383
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 0
- reports, 12 months to August 2026
- 2 in the 12 months before
- 98.4%
- classified as malfunction
- 76.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 383 reports that name the brand "Accu-Chek Linkassist" (spring loaded insertion device), received between January 2012 and November 2024; the manufacturer given most often on reports is Roche Diabetes Care. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 2 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 (98.4%) and injury (1.6%); across all introducer, syringe needle reports (product code KZH) death is recorded in 0.1% and malfunction in 76.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unintended ejection (54%), misfire (36.8%) and device operates differently than expected (2.3%). The patient problems coded most often are needle stick/puncture, aneurysm 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 1,079 reports carrying product code KZH. 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 |
|---|---|---|---|
| Unintended ejection | 207 | 54% | 32.2% |
| Misfire | 141 | 36.8% | 19.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 2.3% | 4.3% |
| Ejection problem | 2 | 0.5% | 0.4% |
| Insufficient device problem information | 2 | 0.5% | 2.2% |
| Self-activation or keying | 2 | 0.5% | 0% |
| Defective devicethe device was defective | 1 | 0.3% | 2.6% |
| Device dislodged or dislocated | 1 | 0.3% | 0.1% |
| Device displays incorrect message | 1 | 0.3% | 1.6% |
| Device slipped | 1 | 0.3% | 0.2% |
| Difficult to insertthe device was hard to insert | 1 | 0.3% | 1.7% |
| Difficult to removethe device was hard to remove | 1 | 0.3% | 0.4% |
| Fail-safe problem | 1 | 0.3% | 0.1% |
| Failure to fire | 1 | 0.3% | 0.1% |
| Improper or incorrect procedure or method | 1 | 0.3% | 1% |
| Mechanical problema mechanical problem | 1 | 0.3% | 0.4% |
| Sticking | 1 | 0.3% | 4.2% |
| Unintended system motionthe device moved when it should not have | 1 | 0.3% | 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 | 8 | 2.1% |
| Aneurysm | 6 | 1.6% |
| Hyperglycemiahigh blood sugar | 4 | 1% |
| Eye injury | 2 | 0.5% |
| Abrasion | 1 | 0.3% |
| Cataractclouding of the eye lens | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Accu-Chek Linkassist | Product code KZH | All MAUDE reports |
|---|---|---|---|
| Reports | 383 | 1,079 | 26,136,888 |
| Share of that pool | — | 35.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 1.6% | 22.1% | 36.2% |
| Classified as malfunction | 98.4% | 76.8% | 62.3% |
| Filed by the manufacturer | 100% | 75% | 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 KZH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Accu-Chek Linkassist Plus Insertion Device | 193 | 0 | 0% |
| Paradigm Quickserter | 246 | 0 | 0% |
| Monoject | 430 | 14 | 0.2% |
| Novopen 3 | 257 | 5 | 2.3% |
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 Accu-Chek Linkassist reports
How many FDA reports name Accu-Chek Linkassist?
383 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?
malfunction (98.4%) and injury (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended ejection (54%), misfire (36.8%), device operates differently than expected (2.3%), ejection problem (0.5%) and insufficient device problem information (0.5%). 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 Accu-Chek Linkassist 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.