MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-25 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.
[136147974]
(b)(4). Device evaluation by manufacturer: a field service engineer (fse) visited the customer's site to address the reported event. Fse was able to reproduce error when the instrument was powered up. Fse replaced the faulty sample needle, cleaned and lubricated sampling mechanism. Fse successfully completed quality control without any errors. No further action required by field service. The g8 instrument is functioning as expected. A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) through aware date. There were no similar complaints identified during the search period. The g8 variant analysis mode operator's manual under chapter 5, maintenance procedures, under section 5. 10 provides step-by-step instructions on the sampling needle assembly replacement. 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. 710 z1-axis error: an abnormality occurred in the up and down movement of the sampling needle. If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set. The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor. The most probable cause of the reported event was due the faulty sample needle.
Patient Sequence No: 1, Text Type: N, H10
[136147975]
A customer reported getting frequent 710 z1-axis error messages during sample run on the g8 instrument. 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 | 8031673-2018-05443 |
| MDR Report Key | 8280119 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-12-31 |
| Date Facility Aware | 2018-12-31 |
| Report Date | 2019-01-25 |
| Date Reported to FDA | 2019-01-25 |
| Date Reported to Mfgr | 2019-01-25 |
| Date Mfgr Received | 2018-12-31 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2019-01-25 |
| 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 | 6509368123 |
| Manufacturer G1 | TOSOH CORPORATION (MANUFACTURER) |
| Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, TOKYO, JAPAN 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 | 2019-01-25 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 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, JAPAN 1058623 JA 1058623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-25 |