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 2017-10-07 for ADVIA CENTAUR XPT manufactured by Siemens Healthcare Diagnostics Inc..
[89745568]
The customer contacted the siemens customer care center (ccc) to report the discordant alpha fetoprotein (afp) result. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse checked the reagent, which had no problems. The cse replaced all aspirate pinch valves and pinch valve tubing, all aspirate probe guides, and reagent probe 1 diluter. The cse aligned reagent probe 1 and aspirate probes to the incubation ring. The cse cleaned probes and lubricated lead screws. The cse checked dispense for acid, base, and reagent probes. The cse performed an afp precision run of 10 replicates of level 1 and level 2 controls. Quality controls (qc) were confirmed and the system was operational. The cause of the discordant afp result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[89745569]
A discordant, falsely high alpha fetoprotein (afp) result was obtained on one patient sample on an advia centaur xpt instrument. The discordant result was not reported to the physician(s). The same sample was tested on the same and an alternate instrument, resulting lower. The result obtained from an alternate instrument was reported to physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant afp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00546 |
| MDR Report Key | 6926056 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-07 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-07-19 |
| Date Mfgr Received | 2017-07-19 |
| Device Manufacturer Date | 2015-09-10 |
| Date Added to Maude | 2017-10-07 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMIT |
| Manufacturer Street | CHAPEL LANE REGISTRATION NUMBER: 8020888 |
| Manufacturer City | 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 | ADVIA CENTAUR XPT |
| Product Code | CDZ |
| Date Received | 2017-10-07 |
| 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 XPT |
| Generic Name | ADVIA CENTAUR XPT |
| Product Code | JJE |
| Date Received | 2017-10-07 |
| 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 | 2017-10-07 |