MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-09-04 for ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY N/A 10310283 manufactured by Siemens Healthcare Diagnotics, Inc.
[119044963]
The cause of the discordant advia centaur xp rubella g result is unknown. Siemens healthcare diagnostics is investigating. Mdr 1219913-2018-00213 was filed for elevated advia centaur xp rubella g results when compared to an alternate method from the same patient in (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10
[119044964]
Customer observed an elevated advia centaur xp rubella igg (rubg) result compared to an alternate method. There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur rubella igg result. The patient was redrawn and will likely receive a booster for rubella. Mdr 1219913-2018-00213 was filed for elevated advia centaur xp rubella g results when compared to an alternate method from the same patient in (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00212 |
| MDR Report Key | 7841908 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-04 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-03-22 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2017-10-09 |
| Date Added to Maude | 2018-09-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY |
| Generic Name | RUBELLA G IMMUNOASSAY |
| Product Code | LFX |
| Date Received | 2018-09-04 |
| Model Number | N/A |
| Catalog Number | 10310283 |
| Lot Number | 45524201 |
| Device Expiration Date | 2018-10-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOTICS, INC |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-04 |