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 2018-10-08 for ADVIA CENTAUR XPT RUBELLA G (RUB G) ASSAY N/A 10310283 manufactured by Siemens Healthcare Diagnostics, Inc..
[125134833]
The cause for the discordant advia centaur xpt rubella g (rub g) results obtained on a patient sample from two different reagent lots is unknown. Siemens is investigating. Mdr 1219913-2018-00246 was filed for an initial false positive result from the same patient.
Patient Sequence No: 1, Text Type: N, H10
[125134834]
False positive advia centaur xpt rubella g (rub g) results were obtained on a patient sample from two different reagent lots. The positive results were considered discordant compared to negative rubella g alternate test method result(s) during the patient's pregnancy. There are no reports that treatment was altered or prescribed or adverse health consequences due to the positive advia centaur xpt rubella igg results. Mdr 1219913-2018-00246 was filed for an initial false positive result from the same patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00247 |
| MDR Report Key | 7945061 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-08 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2018-10-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| 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 XPT RUBELLA G (RUB G) ASSAY |
| Generic Name | RUBELLA G IMMUNOASSAY |
| Product Code | LFX |
| Date Received | 2018-10-08 |
| Model Number | N/A |
| Catalog Number | 10310283 |
| Lot Number | 068202 |
| Device Expiration Date | 2018-12-14 |
| 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 DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-08 |