MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-12 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.
[102468111]
A field service engineer (fse) made service call on (b)(6) 2015. The fse replaced the main pump and pump seal, rotor seal, stator face, and sample loop. The fse replaced all peek tubing in high pressure side along with the pre-filter and buffer files, flushed the flow cell and inspected the degrasser and all tubing connections. The fse adjusted the flow rate and observed normal and steady pressure. The customer ran qc and 160 patients with no errors. No further action was required by fse. The g8 analyzer is in good working condition and was functioning as intended and the issue cleared. No further action required by field service. The most probable cause of the reported event was due to a mechanical failure of main pump. (b)(4). This report is being submitted due to a retrospective review conducted under capa-(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102468112]
On (b)(6) 2015 a customer reported ongoing problems with retention time and gets numerous front peak flags with the g8 analyzer. The customer is unable to run hba1c in the patient samples. A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hba1c patient results. There was no indication of any patient intervention or adverse health consequences due to the delay in reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031673-2018-01852 |
| MDR Report Key | 7332651 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-12 |
| Date of Report | 2018-03-12 |
| Date Facility Aware | 2015-12-24 |
| Report Date | 2018-03-12 |
| Date Reported to FDA | 2018-03-12 |
| Date Reported to Mfgr | 2018-03-12 |
| Date Mfgr Received | 2015-12-24 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2018-03-12 |
| 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) |
| 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 | LPC |
| Date Received | 2018-03-12 |
| 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 | 2018-03-12 |