MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-25 for TOSOH HLC-723G8 ANALYZER G8 021560 manufactured by Tosoh Corporation.
[147064170]
A field service engineer (fse) evaluated the analyzers at the customer's sites and was able to replicate reported events. For 1 of 3 events, fse replaced the loader assembly. For 2 of 3 events fse removed debris and cleaned the loader areas. The three (3) g8 analyzers were repaired and returned to operational status.
Patient Sequence No: 1, Text Type: N, H10
[147064171]
This report summarizes 3 malfunction events for the g8 analyzer. The review of events indicated that the analyzer experienced sample loading error messages, which caused delay in reporting of patient results for hemoglobin a1c (hba1c). These reports were received from various sources. There was no indication of patient intervention or adverse health consequences due to the delayed reporting in patient results. None of these events necessitated remedial action to prevent an unreasonable risk of substantial harm to the public health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031673-2019-00113 |
| MDR Report Key | 8550806 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date Added to Maude | 2019-04-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DORIA ESQUIVEL |
| Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
| Manufacturer City | MINATO-KU, TOKYO, JAPAN 1058623 |
| Manufacturer Country | JA |
| Manufacturer Postal | 1058623 |
| Manufacturer G1 | TOSOH CORPORATION |
| 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 | 2019-04-25 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-04-25 |