MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-03 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.
[132924801]
(b)(4). Fse arrived onsite to address the reported event. Fse confirmed and reproduced the "708 x-axis" error, then cleaned and lubricated the x-axis rails, which resolved the issue. Fse validated the device. No further issues were noted. No further action was required by field service. A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 12nov2017 through aware date (b)(6) 2018. There were two similar complaints identified during the search period. The g8 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. 708 x1-axis error: explanation: operation error in x1-axis. Countermeasure: inspect x1-axis. Inspect x1-axis. Execute sl rotate. The most probable cause of the reported event was due to the sample loader being dirty and requiring lubrication.
Patient Sequence No: 1, Text Type: N, H10
[132924802]
It was reported that the customer received more than twenty "708 x1-axis" errors with their g8 analyzer. The customer attempted the sample loader rotation; however, the issue persisted. 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 was 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 | 8031673-2018-05378 |
| MDR Report Key | 8215013 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-03 |
| Date of Report | 2018-01-03 |
| Date of Event | 2018-12-11 |
| Date Facility Aware | 2018-12-12 |
| Report Date | 2018-01-03 |
| Date Reported to FDA | 2018-01-03 |
| Date Reported to Mfgr | 2018-01-03 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2019-01-03 |
| 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, |
| 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 | 2019-01-03 |
| 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 105-8623 JA 105-8623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-03 |