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 2017-03-28 for ADVIA CENTAUR XPT manufactured by Siemens Healthcare Diagnostics Inc..
[71054470]
A siemens customer service engineer was dispatched to the customer site. After evaluating the instrument, the cse replaced multiple parts (pinch valves, pinch valve tubings, tubing between pinch valve and waste reservoir, probe, heater coil, two-way valves of water line, and base pump). The cse also checked and replaced the aspirate probe guides, adjusted the incubation ring, reagent probe, aspirate probe, and vacuum flow. The cse then cleaned the probes and luminometer and lubricated the lead screws. The cse verified proper functioning of dispense, acid and base and reagent probes. The cse performed decontamination and precision testing. Quality controls were within acceptable range. The cause of the discordant, falsely elevated cea results on two patient samples 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
[71054471]
Discordant, falsely elevated carcinoembryonic antigen (cea) results were obtained on two patient samples on an advia centaur xpt instrument. The discordant results were not reported to the physician(s). The samples were repeated on an alternate advia centaur xpt instrument, resulting lower. The results obtained on the alternate advia centaur xpt instrument were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated cea results.
Patient Sequence No: 1, Text Type: D, B5
[75937982]
The initial mdr 2432235-2017-00216 was filed on march 28, 2017. Additional information (04/26/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer. The information indicated that the customer properly mixes the reagent as per the instructions provided in the advia centaur xpt carcinoembryonic antigen instructions for use. As the siemens customer service engineer replaced multiple parts, the hsc specialist could not determine which mechanical malfunction could have contributed to the discordant results. The hsc specialist was unable to rule out a possible mechanical issue, pre-analytical sample handling issue or an isolated reagent pack issue. The cause of the discordant, falsely elevated carcinoembryonic antigen results on two patient samples is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00216 |
| MDR Report Key | 6439974 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-28 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2015-08-10 |
| Date Added to Maude | 2017-03-28 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| 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 XPT |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | DHX |
| Date Received | 2017-03-28 |
| Model Number | ADVIA CENTAUR XPT |
| 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 |
| Brand Name | ADVIA CENTAUR XPT |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-28 |
| Model Number | ADVIA CENTAUR XPT |
| 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 | 2017-03-28 |