MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-20 for ADVIA CENTAUR XP DIGITOXIN ASSAY N/A 08861968 manufactured by Siemens Healthcare Diagnostics, Inc..
[17130975]
Falsely elevated advia centaur xp digitoxin results were obtained by the customer on a patient sample drawn and tested on different dates. The results have been questioned by the physician as the patient has not received further digitoxin treatment and the results are considered discordant when compared to a lower repeat test result from an alternate digitoxin test method. There was no known report of adverse health consequences due to the discordant digitoxin results.
Patient Sequence No: 1, Text Type: D, B5
[17355264]
The cause for the falsely elevated advia centaur xp digitoxin results when compared to a lower repeat test result from an alternate test method is unknown. The customer has stated that the assay calibrations and quality control results were within specifications. The discordant sample has been request for further investigation. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00397 |
| MDR Report Key | 2840154 |
| Report Source | 05,06 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-10-29 |
| Date of Event | 2012-09-02 |
| Date Mfgr Received | 2012-10-29 |
| Date Added to Maude | 2013-02-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY ST. |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP DIGITOXIN ASSAY |
| Generic Name | DIGITOXIN IMMUNOASSAY |
| Product Code | LFM |
| Date Received | 2012-11-20 |
| Model Number | N/A |
| Catalog Number | 08861968 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-20 |