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 2017-04-03 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[71588519]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated they reviewed the sample and did not find any issues with it. A review of the customer's calibration and quality control (qc), shows it was in range at the time of the event. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse found a base pump leak. The cse installed a new pump and verified proper operation. The cse performed calibration and qc, resulting within range. The customer ran patient samples for verification, resulting within the expected ranges. A siemens headquarters support center (hsc) reviewed the event. Hsc stated this is an inverse assay. With inverse assays, a higher relative light unit (rlu) result would produce a low patient result. A leaking base pump usually indicates that less base was dispensed, causing a lower rlu and a higher result. The cse did not find any system contamination or errors associated with this issue. The issue could not be confirmed. The cause of the discordant, falsely depressed br 27. 29 results 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
[71588520]
Discordant, falsely depressed br 27. 29 (cancer antigen 27. 29) results were obtained on two patient samples on an advia centaur xp instrument. The initial results were reported out to the physician(s), which was questioned. The customer repeated the same samples on the same advia centaur xp instrument, resulting higher. Corrected reports were issued to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed br 27. 29 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00234 |
| MDR Report Key | 6455399 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-03 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-08 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2007-07-30 |
| Date Added to Maude | 2017-04-03 |
| 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 | MOI |
| Date Received | 2017-04-03 |
| 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 | 2017-04-03 |
| 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 | 2017-04-03 |