Devices › Set, administration, intravascular
Device brand name · Subcutaneous infusion set
Accu-Chek Flexlink Infusion Set: medical device reports filed with FDA
1,817 reports name it, 2009–2025. Manufacturer given most often on reports: Roche Diabetes Care. Product code FPA.
- 1,817
- device reports naming the brand
- 0% of all MAUDE reports · about 106 a year
- 0
- reports, 12 months to August 2026
- 83 in the 12 months before
- 85%
- classified as malfunction
- 79.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,817 medical device reports received by FDA name the brand "Accu-Chek Flexlink Infusion Set" (subcutaneous infusion set); the manufacturer given most often on reports is Roche Diabetes Care; received from May 2009 to March 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 83 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 (85%) and injury (15%); across all set, administration, intravascular reports (product code FPA) death is recorded in 0.2% and malfunction in 79.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (31.6%), leak/splash (25.4%) and loss of or failure to bond (14.2%). The patient problems coded most often are hyperglycemia, elevated ketones/ diabetic ketoacidosis 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 349,387 reports carrying product code FPA. 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 |
|---|---|---|---|
| Fluid/blood leak | 574 | 31.6% | 13.5% |
| Leak/splashthe device leaked | 462 | 25.4% | 11.2% |
| Loss of or failure to bond | 258 | 14.2% | 14% |
| Failure to adhere or bond | 134 | 7.4% | 0.4% |
| Detachment of device or device componentpart of the device came off | 57 | 3.1% | 3.9% |
| Disconnection | 43 | 2.4% | 1.8% |
| Material integrity problema problem with the device material | 33 | 1.8% | 0.2% |
| Material separation | 33 | 1.8% | 1.8% |
| Bent | 28 | 1.5% | 0.4% |
| Occlusion within devicethe device blocked | 26 | 1.4% | 0.6% |
| Detachment of device component | 19 | 1% | 0.6% |
| Material twisted/bent | 19 | 1% | 12.2% |
| Connection problema connection problem | 18 | 1% | 0.5% |
| Insufficient device problem information | 11 | 0.6% | 0.3% |
| Defective devicethe device was defective | 9 | 0.5% | 0.2% |
| Device displays incorrect message | 9 | 0.5% | 0.8% |
| Obstruction of flow | 8 | 0.4% | 0.7% |
| Air leak | 7 | 0.4% | 0.4% |
| Device dislodged or dislocated | 6 | 0.3% | 0.1% |
| Material fragmentation | 6 | 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 |
|---|---|---|
| Hyperglycemiahigh blood sugar | 713 | 39.2% |
| Elevated ketones/ diabetic ketoacidosis | 51 | 2.8% |
| Aneurysm | 17 | 0.9% |
| Skin inflammation/ irritation | 12 | 0.7% |
| Reaction, injection site | 11 | 0.6% |
| Hypoglycemialow blood sugar | 10 | 0.6% |
| Vomitingbeing sick | 8 | 0.4% |
| Skin inflammation | 6 | 0.3% |
| Abscessa collection of pus | 5 | 0.3% |
| Administration site reaction | 5 | 0.3% |
| Blood glucose, high | 3 | 0.2% |
| Device embedded in tissue or plaque | 3 | 0.2% |
| Skin irritationirritated skin | 3 | 0.2% |
| Bacterial infectiona bacterial infection | 2 | 0.1% |
| Coma | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Accu-Chek Flexlink Infusion Set | Product code FPA | All MAUDE reports |
|---|---|---|---|
| Reports | 1,817 | 349,387 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 15% | 20% | 36.2% |
| Classified as malfunction | 85% | 79.3% | 62.3% |
| Filed by the manufacturer | 100% | 96.3% | 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 FPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inset Guard | 47,276 | 47,222 | 0.1% |
| Inset | 26,405 | 25,656 | 0% |
| Quick Set | 23,351 | 23,028 | 0.4% |
| Autosoft Xc | 20,328 | 49 | 0% |
| Autosoft 90 | 12,143 | 15 | 0% |
| Access | 14,160 | 0 | 0% |
| Other Accessories | 10,429 | 10,425 | 1.7% |
| Alaris Pump Module Administration Set | 8,492 | 0 | 0.2% |
| Contact Detach | 6,473 | 6,157 | 0.1% |
| Inset 30 | 3,528 | 3,461 | 0% |
| Cadd | 10,811 | 9 | 0.1% |
| Minimed Quick-Set | 3,101 | 6 | 0% |
| Cleo 90 Infusion Set | 3,006 | 23 | 0% |
| Trusteel | 2,886 | 14 | 0% |
| Autosoft 30 | 2,374 | 1 | 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 Accu-Chek Flexlink Infusion Set reports
How many FDA reports name Accu-Chek Flexlink Infusion Set?
1,817 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 (85%) and injury (15%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (31.6%), leak/splash (25.4%), loss of or failure to bond (14.2%), failure to adhere or bond (7.4%) and detachment of device or device component (3.1%). 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 Flexlink Infusion Set 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.