Device brand name · Insulin infusion set
Accu-Chek Flexlink Plus: medical device reports filed with FDA
555 reports name it, 2010–2012. Manufacturer given most often on reports: Roche Insulin Delivery Systems. Product code FRN.
- 555
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 88.3%
- classified as malfunction
- 98.5% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
555 medical device reports received by FDA name the brand "Accu-Chek Flexlink Plus" (insulin infusion set); the manufacturer given most often on reports is Roche Insulin Delivery Systems; received from October 2010 to May 2012. 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, 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 malfunction (88.3%), injury (11.5%) and death (0.2%); across all pump, infusion reports (product code FRN) death is recorded in 0.1% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are nonstandard device (69.4%), high test results (53.2%) and bent (50.1%). The patient problems coded most often are hyperglycemia, elevated ketones/ diabetic ketoacidosis and pain. 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 Accu-Chek Flexlink Plus was received in the five years to August 2026; the latest was received in May 2012.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,831,109 reports carrying product code FRN. 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 |
|---|---|---|---|
| Nonstandard device | 385 | 69.4% | 0.5% |
| High test results | 295 | 53.2% | 0% |
| Bent | 278 | 50.1% | 0.1% |
| Fluid/blood leak | 224 | 40.4% | 0.6% |
| Kinkedthe tube or line kinked | 71 | 12.8% | 0% |
| Difficult to insertthe device was hard to insert | 41 | 7.4% | 0% |
| Device emits odor | 28 | 5% | 0% |
| Occlusion within devicethe device blocked | 25 | 4.5% | 0.6% |
| Malposition of device | 22 | 4% | 0% |
| Device displays incorrect message | 19 | 3.4% | 9.3% |
| Disconnection | 16 | 2.9% | 0% |
| Leak/splashthe device leaked | 15 | 2.7% | 0.3% |
| Difficult to removethe device was hard to remove | 12 | 2.2% | 0% |
| Insufficient flow or under infusion | 12 | 2.2% | 0.8% |
| Breakthe device broke | 9 | 1.6% | 8.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 1.6% | 0.9% |
| Improper or incorrect procedure or method | 9 | 1.6% | 0.1% |
| Detachment of device component | 6 | 1.1% | 0% |
| Device dislodged or dislocated | 6 | 1.1% | 0% |
| Positioning problem | 5 | 0.9% | 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 | 427 | 76.9% |
| Elevated ketones/ diabetic ketoacidosis | 21 | 3.8% |
| Painpain, site not specified | 13 | 2.3% |
| Vomitingbeing sick | 13 | 2.3% |
| Bruise/contusion | 9 | 1.6% |
| Fatiguetiredness | 8 | 1.4% |
| Nauseafeeling sick | 8 | 1.4% |
| Skin irritationirritated skin | 7 | 1.3% |
| Headachehead pain | 5 | 0.9% |
| Polydipsia | 5 | 0.9% |
| Underdoseless than the intended dose | 5 | 0.9% |
| Dizzinesslight-headedness or unsteadiness | 4 | 0.7% |
| Hypoglycemialow blood sugar | 4 | 0.7% |
| Malaisegeneral feeling of being unwell | 4 | 0.7% |
| Abscessa collection of pus | 3 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Accu-Chek Flexlink Plus | Product code FRN | All MAUDE reports |
|---|---|---|---|
| Reports | 555 | 1,831,109 | 26,136,888 |
| Share of that pool | — | 0% | 0% |
| Classified as death, per 1,000 reports | 2 | 1 | 9 |
| Classified as injury | 11.5% | 1.3% | 36.2% |
| Classified as malfunction | 88.3% | 98.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 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 FRN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Alaris Pump Module | 684,522 | 0 | 0% |
| Alaris System | 422,501 | 33,692 | 0% |
| 8100 Alaris Pump Module | 163,620 | 0 | 0% |
| Spectrum Infusion Pump | 147,363 | 15 | 0% |
| 8015 Alaris System Pc Unit | 54,162 | 0 | 0% |
| Alaris System Pc Unit | 24,066 | 0 | 0% |
| 8110 Alaris Syringe Pump | 22,434 | 0 | 0% |
| Colleague | 21,763 | 0 | 0% |
| Reservoir 3ML MMT-332A | 19,914 | 2,008 | 0.4% |
| Reservoir 3ml | 16,407 | 0 | 0.8% |
| Flogard | 15,668 | 0 | 0% |
| Colleague Volumetric Infusion Pump | 13,678 | 0 | 0.1% |
| Colleague Pre P1 7 | 13,103 | 0 | 0% |
| CADD-Solis VIP Ambulatory Infusion Pump | 11,721 | 3,471 | 0.1% |
| Intermate | 8,261 | 47 | 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 Plus reports
How many FDA reports name Accu-Chek Flexlink Plus?
555 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 (88.3%), injury (11.5%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
nonstandard device (69.4%), high test results (53.2%), bent (50.1%), fluid/blood leak (40.4%) and kinked (12.8%). 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 Plus 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.