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 2017-03-16 for ADVIA CENTAUR XP VB12 ASSAY N/A 10309970 manufactured by Siemens Healthcare Diagnostics, Inc..
[70178705]
A siemens customer service engineer (cse) was at the customer site for system inspection. The cse did not observe any instrument issues. The cause for the falsely elevated or imprecise advia centaur xp vb12 (vitamin b12) results when comparing the advia centaur xp systems, or elevated results compared to an alternate vb 12 test method is unknown. Siemens is investigating. The instructions for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[70178706]
Falsely elevated or imprecise advia centaur xp vb12 (vitamin b12) results were observed when comparing the results from one advia centaur xp system to another advia centaur xp system, and in some cases elevated compared to an alternate vb 12 test method. Patient treatment was not prescribed or altered. There was no known report of adverse health consequences due to the reported vb12 results.
Patient Sequence No: 1, Text Type: D, B5
[75955355]
Siemens filed the initial mdr 1219913-2017-00062 on 03/16/2017 for falsely elevated advia centaur xp vb12 (vitamin b12) results. On (b)(6) 2017 - additional information: a siemens customer service engineer (cse) was sent to the customer site. The cse did not identify any instrument related issues that may have contributed to the advia centaur xp elevated results. The cse changed sample tubes, centrifuge speeds, and proactively performed preventive maintenance (pm). The cause for the elevated advia centaur xp vb12 (vitamin b12) results is unknown. No conclusion can be drawn. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2017-00062 |
| MDR Report Key | 6411826 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-16 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-02-19 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2016-06-15 |
| Date Added to Maude | 2017-03-16 |
| 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 | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 105915097 |
| Manufacturer Country | US |
| Manufacturer Postal | 105915097 |
| 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 VB12 ASSAY |
| Generic Name | VB12 IMMUNOASSAY, |
| Product Code | CDD |
| Date Received | 2017-03-16 |
| Model Number | N/A |
| Catalog Number | 10309970 |
| Lot Number | 46513231 |
| Device Expiration Date | 2017-05-15 |
| 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 | 2017-03-16 |