MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-10-15 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[28305685]
The customer contacted the (b)(6) center (ccc). The customer stated that quality controls were within range at the time the discordant result was obtained. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse performed a total service call. The cse lubricated the sample syringe and ran quality controls in replicates, which resulted within range. The cse also adjusted the sample probe calibration to cuvette bottom for dilutions. A precision study was performed post service, with acceptable results. The cause of the discordant, falsely elevated ca 15-3 result 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
[28305686]
A discordant, falsely elevated cancer antigen 15-3 (ca 15-3) result was obtained on one patient sample on an advia centaur xp instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument and an alternate advia centaur instrument, and both resulted lower. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ca 15-3 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2015-00478 |
| MDR Report Key | 5151611 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-15 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2015-09-18 |
| Device Manufacturer Date | 2011-11-21 |
| Date Added to Maude | 2015-10-15 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 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 XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-10-15 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-15 |