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 2016-05-23 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[45706181]
The customer contacted a siemens customer care center (ccc) specialist and stated that quality controls and calibrations were within acceptable ranges. The cause of the discordant, false negative total hcg result on one patient sample is unknown. Siemens healthcare diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[45706182]
A discordant, false negative total human chorionic gonadotropin (total hcg) result was obtained on one patient sample on an advia centaur xp instrument. The discordant result was questioned and the laboratory repeated the sample on the same instrument, resulting positive. It is unknown if the repeat result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative total hcg result.
Patient Sequence No: 1, Text Type: D, B5
[47815623]
The initial mdr 2432235-2016-00261 was filed on may 23, 2016. Additional information (05/09/2016): a siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse replaced the wash manifold, which was leaking, performed a total service call and cleaned the incubation ring. The cse ran quality controls, which were acceptable. The cause of the discordant, false negative total hcg result on one patient sample is unknown. Additional information (06/03/2016): the initial mdr states that it is unknown if the repeat result was reported. Additional information was provided by the customer. The corrected result was reported to the physician(s). The initial mdr states it is unknown if the "initial reporter also sent report to fda". This information has been received from the customer and has been updated.
Patient Sequence No: 1, Text Type: N, H10
[47815624]
A discordant, false negative total human chorionic gonadotropin (total hcg) result was obtained on one patient sample on an advia centaur xp instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument, resulting positive. 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, false negative total hcg result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00261 |
| MDR Report Key | 5672967 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-23 |
| Date of Report | 2016-06-03 |
| Date of Event | 2016-04-28 |
| Date Mfgr Received | 2016-05-09 |
| Device Manufacturer Date | 2007-11-12 |
| Date Added to Maude | 2016-05-23 |
| 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 | NAL |
| Date Received | 2016-05-23 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-23 |