MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-08 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.
[133868258]
(b)(4). Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the event. Fse verified the issue on the error log and reproduced the error by running a patient sample. Fse continued evaluation and observed a leak at the injection valve. Fse disassembled and cleaned the valve head and then reassembled and tightened the injection valve. Fse ran two levels of quality controls and precision with acceptable results. The instrument was operating as expected. There was no further action required by fse. A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 20-nov-2017 through aware date (b)(4) 2018. There were no similar complaints identified during the searched period. The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 6. 3 error messages: when consulting with technical support about a problem, please note the error message and error number. In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support. General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state. 101 pressure low: the pressure will not rise because the pump is unable to run due to air bubbles in the pump check valve. If the elution buffer is empty, place a new elution buffer and execute reagent change. Next, execute drain flush. See "chapter 5 section 5. 5: pump air removal". Execute manual pumping using the pump key in the main screen (second screen), and open and close the drain valve 2 or 3 times. If the pressure rises when the drain valve is closed, the operation is complete. If the pressure still does not rise or stabilize, execute drain flush again. In addition, confirm that the drain valve is securely closed. 600 as no response indicates autosampler is not responding. Troublshooting states "check connections. Turn the main power off then on to re-start. " the most probable cause of the 101 low pressure error was a dirty valve head and loose injection valve.
Patient Sequence No: 1, Text Type: N, H10
[133868259]
A customer reported that they were getting error 101 pressure low while running patient samples on the g8 instrument. The customer stated that they changed the column and the filter but every time a sample is run, the low pressure error occurs. Technical support (ts) instructed the customer to power up the instrument and the pressure was 8. 6 mpa. The customer then ran a sample and the error occurred. The customer ran a drain flush without any issues. Ts sent the customer a replacement sample needle to install. Upon follow up, ts instructed customer to verify all buffer bags were full and buffer suction straws were the correct length. The customer then ran the pump and cycled all buffer valves independently without any drop in pressure. However, when they ran a sample, the pressure dropped again. The customer recycled all buffers valves again and the pressure was stable. The customer then rebooted the instrument and a "as" autosampler not found occurred on initialization. The pressure on each valve was flowing without any drops. However, the pressure dropped when a test sample was run. The instrument was down. A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c). There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031673-2018-05421 |
| MDR Report Key | 8229663 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-12-20 |
| Date Facility Aware | 2018-12-20 |
| Report Date | 2019-01-08 |
| Date Reported to FDA | 2019-01-08 |
| Date Reported to Mfgr | 2019-01-08 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2015-12-01 |
| Date Added to Maude | 2019-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DORIA ESQUIVEL |
| Manufacturer Street | 6000 SHORELINE COURT SUITE 101 |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 6506368123 |
| Manufacturer G1 | TOSOH CORPORATION |
| Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, TOKYO 1058623 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 1058623 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSOH HLC-723G8 ANALYZER G8 |
| Generic Name | G8 |
| Product Code | LCP |
| Date Received | 2019-01-08 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH CORPORATION |
| Manufacturer Address | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO 1058623 JA 1058623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-08 |