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 2016-03-22 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[40937364]
The customer contacted a siemens customer care center (ccc) specialist. Quality controls and calibrations were acceptable when the sample was run. The customer tested the original sample with a non-specific antibody blocking tube and a heterophilic blocking tube, resulting falsely elevated both times. A new sample (redraw 2) was drawn from the patient, also resulting as falsely elevated. The customer could not provide patient sample for further testing. A siemens headquarters support center (hsc) specialist reviewed the data and could not determine the cause of the discordant falsely elevated digoxin results. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[40937365]
Discordant, falsely elevated digoxin results were obtained on one patient sample when run neat and diluted on an advia centaur xp instrument. The discordant result was reported to the physician(s), who questioned it. The physician(s) transferred the patient to a different hospital. A new sample was obtained from the patient and was tested in an alternate laboratory using an alternate methodology, resulting lower. Another new sample was obtained from the patient and was tested by the customer, still resulting falsely elevated. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated digoxin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00146 |
| MDR Report Key | 5516655 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-22 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-02-24 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2014-08-11 |
| Date Added to Maude | 2016-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, CO., DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | KXT |
| Date Received | 2016-03-22 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-03-22 |
| Model Number | ADVIA CENTAUR XP |
| 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 | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-22 |