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.
[102348003]
Field service engineer (fse) made service call on (b)(6) 2015. Customer reported low pressure. Found leak at rotary valve. Performed yearly pm at the same time. Fse made follow-up call on (b)(6) 2015, and customer reported now having many samples with high total area. Fse asked her to run a few samples without the caps on the tubes with no high total areas. Fse asked customer to replace sample needle and was informed they were too busy. Fse came back and replaced the sample needle (from customer stock) and ran 40 samples with no high areas. 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 probable cause of the event was air in the lines. A complaint history review for serial number (b)(4) was conducted from 15-apr-2014 through (b)(6) 2015 for similar complaints. There were two (2) similar complaint to the present issue. (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
[102348004]
On (b)(6) 2015 a customer reported the g8 analyzer was experiencing high pressure, then leak at filter and low pressure. 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 | 8031673-2018-01850 |
| MDR Report Key | 7330714 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-12 |
| Date of Report | 2018-03-12 |
| Date Facility Aware | 2015-05-15 |
| Report Date | 2018-03-12 |
| Date Reported to FDA | 2018-03-12 |
| Date Reported to Mfgr | 2018-03-12 |
| Date Mfgr Received | 2015-05-15 |
| Device Manufacturer Date | 2010-03-01 |
| 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 | 5 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 |