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 2017-02-13 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[67334640]
A siemens's customer service engineer (cse) was dispatched to the customer's site. The cse performed a total service call. The cse found the wash displacement diluter was letting air into the line. The cse replaced and primed the wash displacement diluter. The customer performed quality control (qc), resulting in range. A siemens headquarters support center (hsc) specialist reviewed the event. Hsc stated that the wash displacement dispense is not used for the carcinoembryonic antigen method. This event was the only instance of a discordant result and was not reproduced. The cause of the discordant, falsely depressed carcinoembryonic antigen 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
[67334641]
A discordant, falsely depressed carcinoembryonic antigen result was obtained on a patient sample on an advia centaur xp instrument. The initial result was reported out to the physician(s), which was questioned. The customer repeated the same sample on the same advia centaur instrument twice, resulting higher. The customer filed a corrected report to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed carcinoembryonic antigen result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00120 |
| MDR Report Key | 6327586 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-01-20 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 2014-11-03 |
| Date Added to Maude | 2017-02-13 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 CHAPEL LANE |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DHX |
| Date Received | 2017-02-13 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-13 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |