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 2017-09-11 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[86162522]
The customer contacted the siemens customer care center (ccc) to report the discordant total prostate-specific antigen (psa) result. A siemens customer service engineer (cse) was dispatched to the customer site. The cse checked the instrument. The cse noticed water bubbles under the wash manifold. The cse replaced manifold and sensor cuvette loader. The cse opened, cleaned and recalibrated the ancillary reagent compartment fridge. The cause of the discordant psa 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
[86162523]
A discordant, falsely high total prostate-specific antigen (psa) result was obtained on a patient sample on an advia centaur xp instrument. The discordant result was reported to the physician(s), who questioned it. A new sample was obtained from the patient and tested on an alternate instrument in another lab, resulting lower. The corrected result was reported to physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant psa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00506 |
| MDR Report Key | 6855644 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-11 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-11-02 |
| Device Manufacturer Date | 2012-02-06 |
| Date Added to Maude | 2017-09-11 |
| 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 LTD |
| 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 XP |
| Generic Name | ADVIA CENTAUR XP |
| Product Code | LTJ |
| Date Received | 2017-09-11 |
| 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 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | ADVIA CENTAUR XP |
| Product Code | JJE |
| Date Received | 2017-09-11 |
| Model Number | ADVIA CENTAUR XP |
| 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 | 2017-09-11 |