MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-07-08 for ADVIA CENTAUR manufactured by Siemens Healthcare Diagnostics Inc..
[6829184]
A discordant, falsely low cancer antigen 19-9 (ca 19-9) result was obtained on one patient sample on an advia centaur instrument. The discordant result was reported to the physician(s), who questioned it. The sample was diluted with a 1:10 dilution factor and was tested on the same instrument, resulting higher. 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 low ca 19-9 result.
Patient Sequence No: 1, Text Type: D, B5
[14251683]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse performed a total service call but could not find an instrument malfunction. The quality controls were within the acceptable ranges. The cause of the discordant, falsely low ca 19-9 result on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[58747600]
The initial mdr 2432235-2015-00319 was filed on july 8, 2015. A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse performed a total service call but could not find an instrument malfunction. The quality controls were within the acceptable ranges. The cause of the discordant, falsely low ca 27. 29 result on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required. Corrected information (10/18/2016): the initial mdr states the method name as cancer antigen 19-9. The correct method name is cancer antigen 27. 29.
Patient Sequence No: 1, Text Type: N, H10
[58747601]
A discordant, falsely low cancer antigen 27. 29 (ca 27. 29) result was obtained on one patient sample on an advia centaur instrument. The discordant result was reported to the physician(s), who questioned it. The sample was diluted with a 1:10 dilution factor and was tested on the same instrument, resulting higher. 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 low ca 27. 29 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2015-00319 |
| MDR Report Key | 4899350 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-07-08 |
| Date of Report | 2016-10-18 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2016-10-18 |
| Device Manufacturer Date | 2005-04-25 |
| Date Added to Maude | 2015-08-03 |
| 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 | 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 |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | NIG |
| Date Received | 2015-07-08 |
| Model Number | ADVIA CENTAUR |
| 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 |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-07-08 |
| Model Number | ADVIA CENTAUR |
| Operator | HEALTH PROFESSIONAL |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-08 |