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 2017-11-07 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[92201043]
The customer contacted the siemens customer care center (ccc) due to quality control (qc) out of range on multiple assays. A siemens customer service engineer (cse) was dispatched to the customer's site. After inspecting all dispenses and aspirations at the wash manifold, the cse observed aspirate probe 1 not aspirating properly. The cse inspected pinch valve and tubing. The cse found that aspirate probe 1 tubing had a break and replaced it. The cse performed empty and fill cuvettes. The cse ran qc, resulting satisfactory. The cause of this issue was the split aspirate tube. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[92201044]
Discordant falsely elevated prostate specific antigen (psa) results were obtained on two patient samples on an advia centaur xp instrument. The discordant results were reported to the physician(s). The samples were repeated on the same instrument two days later post service, resulting lower. The corrected results were reported to physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated psa results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00595 |
| MDR Report Key | 7007859 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-07 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-13 |
| Device Manufacturer Date | 2007-09-10 |
| Date Added to Maude | 2017-11-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. 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 INC. |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, DUBLIN, SWORDS, |
| 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 | LTJ |
| Date Received | 2017-11-07 |
| Model Number | ADVIA CENTAUR XP |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |