Device brand name · Glucose monitoring sys/kit
One Touch Ultra: medical device reports filed with FDA
16,425 reports name it, 2001–2006. Manufacturer given most often on reports: Lifescan. Product code CFR.
- 16,425
- device reports naming the brand
- 0.1% of all MAUDE reports · about 644 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 92.5%
- classified as malfunction
- 83.6% across the product code
- 0%
- classified as death, as reported
- 3 reports · not verified by FDA
16,425 medical device reports received by FDA name the brand "One Touch Ultra" (glucose monitoring sys/kit); the manufacturer given most often on reports is Lifescan; received from January 2001 to December 2006. 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 (92.5%) and injury (6.6%); across all hexokinase, glucose reports (product code CFR) death is recorded in 0.1% and malfunction in 83.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect or inadequate test results (63.1%), replace (30.8%) and high test results (17.9%). The patient problems coded most often are blood glucose, high, treatment with medication(s) and hospitalization required. 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 One Touch Ultra was received in the five years to August 2026; the latest was received in December 2006.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 37,537 reports carrying product code CFR. 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 |
|---|---|---|---|
| Incorrect or inadequate test results | 10,361 | 63.1% | 56.7% |
| Replace | 5,051 | 30.8% | 22.8% |
| High test results | 2,948 | 17.9% | 18% |
| Device displays incorrect message | 887 | 5.4% | 4.9% |
| Failure to power up | 835 | 5.1% | 3.4% |
| Low test results | 773 | 4.7% | 7% |
| High readingsreadings were too high | 420 | 2.6% | 5.3% |
| Use of incorrect control/treatment settings | 355 | 2.2% | 0.3% |
| Unable to obtain readings | 289 | 1.8% | 2.5% |
| Device issuea problem with the device | 208 | 1.3% | 1.3% |
| Erratic or intermittent display | 205 | 1.2% | 1.3% |
| No display/image | 202 | 1.2% | 1.7% |
| Repair | 202 | 1.2% | 0.8% |
| Malfunction | 193 | 1.2% | 0.4% |
| Loss of powerthe device lost power | 190 | 1.2% | 1.1% |
| Device damaged prior to usethe device was damaged before use | 142 | 0.9% | 0.3% |
| Device expiration issue | 136 | 0.8% | 1.5% |
| Incorrect measurementthe device measured wrongly | 116 | 0.7% | 0.2% |
| Peeled/delaminated | 100 | 0.6% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 92 | 0.6% | 0.9% |
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 |
|---|---|---|
| Blood glucose, high | 1,610 | 9.8% |
| Treatment with medication(s) | 1,324 | 8.1% |
| Hospitalization required | 917 | 5.6% |
| Therapy/non-surgical treatment, additional | 850 | 5.2% |
| Blood glucose, low | 516 | 3.1% |
| Dizzinesslight-headedness or unsteadiness | 387 | 2.4% |
| Shaking/tremors | 314 | 1.9% |
| Other (for use when an appropriate patient code cannot be identified) | 295 | 1.8% |
| Hypoglycemialow blood sugar | 284 | 1.7% |
| Sweating | 282 | 1.7% |
| Hyperglycemiahigh blood sugar | 245 | 1.5% |
| Loss of consciousnesspassing out | 210 | 1.3% |
| Weakness | 178 | 1.1% |
| Headachehead pain | 155 | 0.9% |
| Therapy/non-surgical treatment, aborted/stopped | 138 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | One Touch Ultra | Product code CFR | All MAUDE reports |
|---|---|---|---|
| Reports | 16,425 | 37,537 | 26,136,888 |
| Share of that pool | — | 43.8% | 0.1% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 6.6% | 14.2% | 36.2% |
| Classified as malfunction | 92.5% | 83.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 99% | 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 CFR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fasttake | 4,173 | 0 | 0% |
| One Touch Profile | 3,032 | 0 | 0% |
| One Touch Basic Enhanced | 2,741 | 0 | 0% |
| Accu-Chek Comfort Curve | 4,120 | 0 | 0.6% |
| Surestep | 5,323 | 0 | 0.1% |
| One Touch Basic | 2,244 | 0 | 0% |
| Precision Qid Glucose Meter | 561 | 0 | 0.4% |
| Accu-Chek Advantage | 1,290 | 0 | 0.5% |
| Glucometer Dex | 442 | 0 | 0% |
| Medisense Companion 2 Meter | 390 | 0 | 0% |
| One Touch Ultrasmart | 658 | 0 | 0% |
| Quick Check One | 276 | 0 | 0% |
| Precision Xtra Monitor | 318 | 0 | 0.6% |
| One Touch Basic Original | 243 | 0 | 0% |
| Induo | 326 | 0 | 0.3% |
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 One Touch Ultra reports
How many FDA reports name One Touch Ultra?
16,425 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 (92.5%) and injury (6.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect or inadequate test results (63.1%), replace (30.8%), high test results (17.9%), device displays incorrect message (5.4%) and failure to power up (5.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that One Touch Ultra 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.