N
Patient 1
THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE G8 ANALYZER AT THE CUSTOMER'S SITE. FSE PERFORMED DECONTAMINATION OF THE ANALYZER WHICH RESOLVED THE REPORTED ISSUE. THE ANALYZER WAS OPERATIONAL. NO FURTHER ACTION WAS REQUIRED BY FSE.
MAUDE MDR 8552990
- MDR report key
- 8552990
- Report number
- 8031673-2019-00052
- Event key
- 0
- Event type
- 3
- Date received
- 2019-04-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. DORIA ESQUIVEL
- Address
- SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO 10586 JA
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | G8 | G8 | TOSOH CORPORATION | LCP | G8 | 021560 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-25 | 0 |
Event Narratives#
D
Patient 1
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT ON THE G8 ANALYZER. THE REVIEW OF THE EVENT INDICATED THAT THE G8 ANALYZER EXPERIENCED A RETENTION TIME ERROR FLAG. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAYED REPORTING IN PATIENT RESULTS. THIS EVENT DID NOT NECESSITATE REMEDIAL ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH.