MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.
[101586792]
On (b)(6) 2016 a field service engineer (fse) spoke with the customer on the phone and provided instructions on how to clean the lead screw, guide shaft, and the o-rings. Fse advised the customer to replace the sample needle since the original needle is bent. The customer tested the instrument by running quality controls (qc) and patient samples. All results were within acceptable range and encountered no issues. The g8 instrument was functioning as intended and the errors cleared. No further action required by field service. A complaint and service history review for serial number (b)(4) was conducted from (b)(6) 2015 through (b)(6) 2016 for similar complaints. There was one (1) similar complaint to the present issue. This report is being submitted due to a retrospective review conducted under capa-(b)(4). (b)(4) is submitting on behalf of the foreign manufacturer tosoh corporation, per exemption number (b)(4). The probable cause of the event was a dirty guide shaft and lead screw for z-axis.
Patient Sequence No: 1, Text Type: N, H10
[101586793]
On (b)(6) 2016 a customer reported error 710 (z1 axis errors) with the g8 analyzer. The customer stated that changing the needle did not resolve the issue. 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 | 8031673-2018-01805 |
| MDR Report Key | 7305049 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-28 |
| Date Facility Aware | 2016-05-02 |
| Report Date | 2018-02-28 |
| Date Reported to FDA | 2018-02-28 |
| Date Reported to Mfgr | 2018-02-28 |
| Date Mfgr Received | 2016-05-02 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2018-02-28 |
| 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 | 0 |
| Brand Name | TOSOH HLC-723G8 ANALYZER G8 |
| Generic Name | G8 |
| Product Code | LPC |
| Date Received | 2018-02-28 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-02-28 |