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 2018-10-29 for ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY N/A 10310283 manufactured by Siemens Healthcare Diagnostics, Inc..
[126541960]
The cause for the discordant advia centaur xp rubella g (rub g) results for this patient (pregnant female) with two different reagent lots (lot 068202, and lot 068204) is unknown. The customer did not report other discordant rubella g results for other patients at the time of the incident. Siemens is investigating the event. Mdr 1219913-2018-00264 was filed for a false positive result for the same patient, new sample, and tested on another reagent lot (068204).
Patient Sequence No: 1, Text Type: N, H10
[126541961]
A false positive advia centaur xp rubella g (rub g) result was obtained on a pregnant female, and the result was questioned by the physician. The rubella g positive result was considered discordant compared to a negative historical rubella g alternate test method result. A new sample was obtained from the same patient at a later date, run on the same advia centaur xp instrument, different reagent lot (068204), and the rubella g result was positive. This new sample was sent to three alternate support laboratories, tested on alternate rubella g test methods, and the results were all negative. 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 discordant advia centaur xp rubella igg results. Mdr 1219913-2018-00264 was filed for a false positive result for the same patient, new sample, and tested on another reagent lot (068204).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00263 |
| MDR Report Key | 8015528 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-29 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2018-10-29 |
| 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 | 2018-10-29 |
| 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 | 2018-10-29 |