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.
[146090213]
Field service engineers (fse) evaluated the fluidics on 11 of the 15 g8 analyzers at the customers' sites. Four (4) of the 15 events were evaluated by the fses over-the-phone with the customers. The fses resolved the issues by replacing fluidic components. Two (2) of the reported events could not be replicated. The g8 analyzers were repaired and returned to operational status.
Patient Sequence No: 1, Text Type: N, H10
[146090214]
This report summarizes 15 malfunction event on the g8 analyzer. The review of these events indicated that the g8 analyzers experienced fluidics failures, which caused delayed reporting of hemoglobin a1c (hba1c) patient results. These reports were received from various sources. Of the 15 events, 2 events involved patient samples with no indication of patient intervention or adverse health consequences due to the delayed reporting in patient test 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 | 8031673-2019-00123 |
| MDR Report Key | 8552817 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-25 |
| Date of Report | 2019-08-09 |
| Date Mfgr Received | 2019-06-29 |
| 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 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 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 Age | DA |
| 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 1058623 JA 1058623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |