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.
[146531957]
For all 7 reported events, a field service engineer (fse) evaluated the analyzers at the customer sites and was able to confirm the pump unit errors. The fse replaced the pump components and assemblies for 6 of the 7 events. And for 1 of 7 events, the fse found air in lines which was flushed out. 2 of 7 pumps were returned to instrument service center, and further confirmed pumps were faulty; 1 had a cam shaft fault and the other had faulty check valves. No additional issues have been reported by the facilities. All seven (7) g8 analyzers were repaired and returned to operational status.
Patient Sequence No: 1, Text Type: N, H10
[146531958]
This report summarizes 7 malfunction events for the g8 analyzers. The review of events indicated that the g8 analyzer experienced pump 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 | 8031673-2019-00111 |
| MDR Report Key | 8550797 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-25 |
| Date of Report | 2019-08-09 |
| 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 |
| Returned To Mfg | 2019-04-12 |
| Model Number | G8 |
| Catalog Number | 021560 |
| Device Availability | R |
| 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, JAPAN 1058623 JA 1058623 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |