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 2019-04-17 for ADVIA CENTAUR XP RUBELLA G (RUB G) N/A 10310283 manufactured by Siemens Healthcare Diagnostics, Inc..
[145962267]
The cause for the discordant rubella g results is unknown. Siemens healthcare diagnostics is investigating. The ifu states in the warning section: "the use of the advia centaur rubella g assay to diagnose recent infection by testing acute and convalescent samples is not recommended. The calculated values for rubella igg in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the rubella igg assay used. Values obtained with different assay methods cannot be used interchangeably. The reported igg level cannot be correlated to an endpoint titer. " mdr 1219913-2019-00053 (patient 1) and 1219913-2019-00054 (patient 2) were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[145962268]
A false positive advia centaur xp rubella g (rub g) result was obtained for a patient sample. The patient sample was tested on an alternate method and the result was negative. The physician questioned the positive result. A corrected report was issued. The patient is pregnant. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the discordant rubella g result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2019-00055 |
| MDR Report Key | 8524859 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2018-07-19 |
| Date Added to Maude | 2019-04-17 |
| 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 | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE, MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. 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) |
| Generic Name | RUBELLA G IMMUNOASSAY |
| Product Code | LFX |
| Date Received | 2019-04-17 |
| Model Number | N/A |
| Catalog Number | 10310283 |
| Lot Number | 68942208 |
| Device Expiration Date | 2019-07-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-04-17 |