Devices › Assay, glycosylated hemoglobin
Device brand name · G8
Tosoh Hlc-723g8 Analyzer G8: medical device reports filed with FDA
1,343 reports name it, 2018–2020. Manufacturer given most often on reports: Tosoh. Product code LCP.
- 1,343
- device reports naming the brand
- 0% of all MAUDE reports · about 158 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 96.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,343 reports that name the brand "Tosoh Hlc-723g8 Analyzer G8" (G8), received between January 2018 and August 2020; the manufacturer given most often on reports is Tosoh. Spellings of one product vary from report to report.
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 (100%); across all assay, glycosylated hemoglobin reports (product code LCP) death is recorded in 0% and malfunction in 96.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (30.2%), device displays incorrect message (19.1%) and device operational issue (15%). The patient problems coded most often are therapeutic response, decreased, missing value reason and test result. 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 Tosoh Hlc-723g8 Analyzer G8 was received in the five years to August 2026; the latest was received in August 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,951 reports carrying product code LCP. 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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 405 | 30.2% | 21.5% |
| Device displays incorrect message | 256 | 19.1% | 15.2% |
| Device operational issue | 202 | 15% | 15.8% |
| Mechanical problema mechanical problem | 169 | 12.6% | 8% |
| Incorrect, inadequate or imprecise result or readings | 93 | 6.9% | 8.4% |
| Increase in pressure | 85 | 6.3% | 3.2% |
| Decrease in pressure | 53 | 3.9% | 2.1% |
| Incorrect or inadequate test results | 52 | 3.9% | 6.6% |
| Leak/splashthe device leaked | 40 | 3% | 1.5% |
| Pressure problem | 40 | 3% | 2.4% |
| Device issuea problem with the device | 22 | 1.6% | 10.7% |
| Fluid/blood leak | 13 | 1% | 0.6% |
| Calibration problem | 12 | 0.9% | 0.9% |
| Computer software problema software problem | 12 | 0.9% | 1.5% |
| Noise, audible | 12 | 0.9% | 0.4% |
| Output problem | 10 | 0.7% | 0.5% |
| Breakthe device broke | 9 | 0.7% | 0.4% |
| Connection problema connection problem | 9 | 0.7% | 0.4% |
| High readingsreadings were too high | 9 | 0.7% | 0.5% |
| Failure to align | 8 | 0.6% | 0.3% |
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 |
|---|---|---|
| Therapeutic response, decreased | 2 | 0.1% |
| Missing value reason | 1 | 0.1% |
| Test result | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Tosoh Hlc-723g8 Analyzer G8 | Product code LCP | All MAUDE reports |
|---|---|---|---|
| Reports | 1,343 | 2,951 | 26,136,888 |
| Share of that pool | — | 45.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0.9% | 36.2% |
| Classified as malfunction | 100% | 96.7% | 62.3% |
| Filed by the manufacturer | 99.9% | 97.9% | 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 LCP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Tosoh Hlc-723g8 Analyzer | 336 | 0 | 0% |
| Tosoh Hlc-723ga Analyzer G8 | 193 | 0 | 0% |
| Dimension R Clinical Chemistry System | 399 | 0 | 0% |
| Dimension Vista R Clinical Chemistry System | 208 | 0 | 0% |
| G7 | 236 | 82 | 0% |
| Aia-900 | 1,377 | 71 | 0% |
| Aia-360 | 1,034 | 42 | 0% |
| Aia-2000 | 969 | 57 | 0% |
| Dimension Clinical Chemistry System | 1,895 | 0 | 0.2% |
| Dimension Exl 200 | 487 | 0 | 0% |
| Dimension Xpand Plus With Hm | 215 | 0 | 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 Tosoh Hlc-723g8 Analyzer G8 reports
How many FDA reports name Tosoh Hlc-723g8 Analyzer G8?
1,343 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (30.2%), device displays incorrect message (19.1%), device operational issue (15%), mechanical problem (12.6%) and incorrect, inadequate or imprecise result or readings (6.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and distributor 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 Tosoh Hlc-723g8 Analyzer G8 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.