Devices › Blood establishment computer software and accessories
Device brand name · Sample pipetter
Ortho Verseia Pipetter: medical device reports filed with FDA
162 reports name it, 2011–2014. Manufacturer given most often on reports: Hamilton Bonaduz. Product code MMH.
- 162
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.4%
- classified as malfunction
- 94.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 162 reports that name the brand "Ortho Verseia Pipetter" (sample pipetter), received between May 2011 and May 2014; the manufacturer given most often on reports is Hamilton Bonaduz. 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 (99.4%); across all blood establishment computer software and accessories reports (product code MMH) death is recorded in 0.9% and malfunction in 94.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to deliver (32.7%), device operates differently than expected (32.1%) and device displays incorrect message (19.1%). The patient problems coded most often are alteration in body temperature and venipuncture. 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 Ortho Verseia Pipetter was received in the five years to August 2026; the latest was received in May 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,040 reports carrying product code MMH. 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 |
|---|---|---|---|
| Failure to deliverthe device did not deliver the dose or item | 53 | 32.7% | 10.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 52 | 32.1% | 27.6% |
| Device displays incorrect message | 31 | 19.1% | 7.6% |
| Aspiration issue | 25 | 15.4% | 23.4% |
| Nonstandard device | 20 | 12.3% | 3.7% |
| Failure to obtain sample | 17 | 10.5% | 1.8% |
| Incorrect or inadequate test results | 8 | 4.9% | 1.6% |
| Component missing | 4 | 2.5% | 0.4% |
| Incorrect, inadequate or imprecise result or readings | 3 | 1.9% | 1.2% |
| Battery problema problem with the battery | 1 | 0.6% | 0% |
| Device alarm system | 1 | 0.6% | 28.7% |
| Positioning problem | 1 | 0.6% | 0% |
| Unable to obtain readings | 1 | 0.6% | 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 |
|---|---|---|
| Alteration in body temperature | 1 | 0.6% |
| Venipuncture | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ortho Verseia Pipetter | Product code MMH | All MAUDE reports |
|---|---|---|---|
| Reports | 162 | 1,040 | 26,136,888 |
| Share of that pool | — | 15.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 9 | 9 |
| Classified as injury | 0% | 1.8% | 36.2% |
| Classified as malfunction | 99.4% | 94.2% | 62.3% |
| Filed by the manufacturer | 100% | 94.2% | 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 MMH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ortho Summit Sample Handling System | 4,182 | 0 | 0% |
| Epic | 429 | 32 | 1.2% |
| Lifeline | 4,877 | 2,117 | 0.4% |
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 Ortho Verseia Pipetter reports
How many FDA reports name Ortho Verseia Pipetter?
162 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 (99.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to deliver (32.7%), device operates differently than expected (32.1%), device displays incorrect message (19.1%), aspiration issue (15.4%) and nonstandard device (12.3%). 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 Ortho Verseia Pipetter 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.