Devices › Visual, pregnancy hcg, prescription use
Device brand name · Meia for measurement of total bhcg
Axsym Total Bhcg: medical device reports filed with FDA
276 reports name it, 1996–2008. Manufacturer given most often on reports: Abbott Diagnostics International. Product code JHI.
- 276
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 68.8%
- classified as malfunction
- 86.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 276 reports that name the brand "Axsym Total Bhcg" (meia for measurement of total bhcg), received between September 1996 and January 2008; the manufacturer given most often on reports is Abbott Diagnostics International. 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 (68.8%), other (27.5%) and injury (3.6%); across all visual, pregnancy hcg, prescription use reports (product code JHI) death is recorded in 0% and malfunction in 86.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (62.7%), incorrect or inadequate test results (17.8%) and device displays incorrect message (12.7%). The patient problems coded most often are treatment with medication(s), surgical procedure and therapy/non-surgical treatment, additional. 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 Axsym Total Bhcg was received in the five years to August 2026; the latest was received in January 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,859 reports carrying product code JHI. 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, inadequate or imprecise result or readings | 173 | 62.7% | 9.8% |
| Incorrect or inadequate test results | 49 | 17.8% | 6.4% |
| Device displays incorrect message | 35 | 12.7% | 1% |
| False positive result | 16 | 5.8% | 35.9% |
| False negative result | 15 | 5.4% | 43.2% |
| False reading from device non-compliance | 3 | 1.1% | 0.2% |
| High test results | 2 | 0.7% | 2.2% |
| Output, low | 2 | 0.7% | 0.1% |
| Calibration error | 1 | 0.4% | 0.1% |
| Erratic or intermittent display | 1 | 0.4% | 0.1% |
| Low readingsreadings were too low | 1 | 0.4% | 0.1% |
| Low test results | 1 | 0.4% | 1.5% |
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 |
|---|---|---|
| Treatment with medication(s) | 11 | 4% |
| Surgical procedure | 6 | 2.2% |
| Therapy/non-surgical treatment, additional | 6 | 2.2% |
| Surgical procedure, unnecessary | 3 | 1.1% |
| Therapy/non-surgical treatment, unncessary | 3 | 1.1% |
| Hospitalization required | 2 | 0.7% |
| Abdominal painstomach or belly pain | 1 | 0.4% |
| Bleeding | 1 | 0.4% |
| Cyst(s) | 1 | 0.4% |
| Misdiagnosis | 1 | 0.4% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.4% |
| Painpain, site not specified | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Axsym Total Bhcg | Product code JHI | All MAUDE reports |
|---|---|---|---|
| Reports | 276 | 3,859 | 26,136,888 |
| Share of that pool | — | 7.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 3.6% | 5.1% | 36.2% |
| Classified as malfunction | 68.8% | 86.3% | 62.3% |
| Filed by the manufacturer | 100% | 98% | 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 JHI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Consult Hcg Urine Cassette 5001 25t | 152 | 0 | 0% |
| Clinitek Status+ | 251 | 25 | 0% |
| Architect I2000sr Analyzer | 1,785 | 0 | 0.1% |
| Abbott Axsym System | 839 | 0 | 0% |
| Dimension | 1,139 | 40 | 0.1% |
| Synchron Lx I 725 Clinical System | 428 | 0 | 0% |
| Access Immunoassay System | 258 | 0 | 0% |
| Architect I2000 Analyzer | 386 | 0 | 0% |
| Cobas 6000 E 601 Module | 887 | 0 | 0% |
| Vitros Eci Immunodiagnostic System | 489 | 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 Axsym Total Bhcg reports
How many FDA reports name Axsym Total Bhcg?
276 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 (68.8%), other (27.5%) and injury (3.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (62.7%), incorrect or inadequate test results (17.8%), device displays incorrect message (12.7%), false positive result (5.8%) and false negative result (5.4%). 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 Axsym Total Bhcg 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.