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 2018-10-09 for ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY N/A 10310283 manufactured by Siemens Healthcare Diagnostics, Inc..
[125478874]
The cause for the non-reproduced discordant advia centaur xp rubella g (rub g) result obtained on a patient sample cannot be determined. The customer's rubella g calibration and quality control (qc) were acceptable, and the sample dispense well was clear. Pre-analytical factors cannot be ruled out, and variables can affect the quality of the sample, and deviation from recommended best practices can lead to erroneous results. There were no other similar complaints for rubella g reagent lot 068204 on review. Based on the available information, rubella igg lot 068204 is performing as intended. The instruction for use (ifu) under the interpretation of results states the following: "samples with a calculated value of less than 5. 0 iu/ml are considered negative for igg antibodies to rubella virus. " "samples with a calculated value greater than or equal to 5. 0 iu/ml and less than or equal to 9. 9 iu/ml are considered equivocal for igg antibodies to rubella virus. Obtain a new specimen and test using the advia centaur rubella g assay. " "samples with a calculated value greater than or equal to 10. 0 iu/ml are considered positive for igg antibodies to rubella virus. " the instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[125478875]
A false positive advia centaur xp rubella g (rub g) result was obtained on a patient sample, and the result was questioned by the physician based on the patient's negative rubella g test history. A second sample was tested by the customer, and the rubella g result was equivocal. The original sample was retested, and the rubella g result was equivocal. A corrected report was issued by the customer. There are no reports that treatment was altered or prescribed or adverse health consequences due to the positive advia centaur xp rubella igg result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00248 |
| MDR Report Key | 7947990 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-09-21 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2018-10-09 |
| 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 XP RUBELLA G (RUB G) ASSAY |
| Generic Name | RUBELLA G IMMUNOASSAY |
| Product Code | LFX |
| Date Received | 2018-10-09 |
| Model Number | N/A |
| Catalog Number | 10310283 |
| Lot Number | 068204 |
| Device Expiration Date | 2019-03-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-09 |