Devices › Method, enzymatic, glucose (urinary, non-quantitative)
Device brand name · Clinitek status+
Clinitek Status+: medical device reports filed with FDA
251 reports name it, 2012–2026. Manufacturer given most often on reports: Siemens Healthcare Diagnostics. Product code JIL.
- 251
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 25
- reports, 12 months to August 2026
- 16 in the 12 months before
- 83.7%
- classified as malfunction
- 85.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 251 reports that name the brand "Clinitek Status+" (clinitek status+), received between August 2012 and August 2026; the manufacturer given most often on reports is Siemens Healthcare Diagnostics. Spellings of one product vary from report to report.
25 reports arrived in the 12 months to August 2026, up 56% from 16 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 (83.7%) and other (3.6%); across all method, enzymatic, glucose (urinary, non-quantitative) reports (product code JIL) death is recorded in 0% and malfunction in 85.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are false negative result (40.6%), smoking (14.3%) and break (9.2%). The patient problems coded most often are no patient involvement, pregnancy and distress. 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 557 reports carrying product code JIL. 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 |
|---|---|---|---|
| False negative result | 102 | 40.6% | 32.3% |
| Smoking | 36 | 14.3% | 8.6% |
| Breakthe device broke | 23 | 9.2% | 3.9% |
| Nonstandard device | 22 | 8.8% | 3.9% |
| Electrical /electronic property probleman electrical or electronic problem | 11 | 4.4% | 4.7% |
| False positive result | 8 | 3.2% | 7.2% |
| Low test results | 5 | 2% | 10.1% |
| Data problem | 3 | 1.2% | 0.7% |
| Defective devicethe device was defective | 3 | 1.2% | 0.5% |
| Failure to power up | 3 | 1.2% | 0.5% |
| Incorrect, inadequate or imprecise result or readings | 3 | 1.2% | 6.1% |
| Loss of powerthe device lost power | 3 | 1.2% | 0.4% |
| Out-of-box failure | 3 | 1.2% | 0.5% |
| Computer operating system problem | 2 | 0.8% | 0.4% |
| Device stops intermittentlythe device stopped now and then | 2 | 0.8% | 0.4% |
| Display or visual feedback problem | 2 | 0.8% | 0.7% |
| Mechanical problema mechanical problem | 2 | 0.8% | 0.4% |
| Non reproducible results | 2 | 0.8% | 2.3% |
| Overheating of device | 2 | 0.8% | 0.4% |
| Calibration problem | 1 | 0.4% | 0% |
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 |
|---|---|---|
| No patient involvement | 13 | 5.2% |
| Pregnancypregnancy | 5 | 2% |
| Distress | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Clinitek Status+ | Product code JIL | All MAUDE reports |
|---|---|---|---|
| Reports | 251 | 557 | 26,136,888 |
| Share of that pool | — | 45.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 2.7% | 36.2% |
| Classified as malfunction | 83.7% | 85.1% | 62.3% |
| Filed by the manufacturer | 100% | 97.7% | 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."
Questions about Clinitek Status+ reports
How many FDA reports name Clinitek Status+?
251 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 25 in the latest 12 months.
What kinds of events are reported?
malfunction (83.7%) and other (3.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
false negative result (40.6%), smoking (14.3%), break (9.2%), nonstandard device (8.8%) and electrical /electronic property problem (4.4%). 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 Clinitek Status+ 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.