MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-12 for ADVIA CENTAUR CP 086-A002-01 manufactured by Siemens Healthcare Diagnostics.
[17214780]
A discordant, (b)(6) antibody (b)(6) to detect igg antibodies, result was obtained on one patient sample on a advia centaur cp instrument. The discordant (b)(6) result was reported to the physician(s), who cancelled the patients embryo inplant and questioned the result. The sample was repeated on the same system, resulting non-(b)(6). The corrected result was reported to the physician(s). There are no reports of adverse health consequences due to the discordant (b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
[17499772]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and instrument data. After data evaluation, the cse performed a total service call on the system. The cse replaced the waste peristaltic pump tubing. The cse checked the aspirate probe sensor and verified dark counts on the system. The cause of the discordant (b)(6) result is unknown. The customer ran quality controls. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00721 |
| MDR Report Key | 4327570 |
| Report Source | 05,06 |
| Date Received | 2014-12-12 |
| Date of Report | 2014-11-18 |
| Date of Event | 2014-11-14 |
| Date Mfgr Received | 2014-11-18 |
| Date Added to Maude | 2014-12-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | STRATEC BIOMEDICAL SWITZERLAND AG |
| Manufacturer Street | REGISTRATION #: 3008494306 GEWERBESTRASSE 6 |
| Manufacturer City | NEUHAUSEN AM RHEINFALL 8212, |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | OBF |
| Date Received | 2014-12-12 |
| Model Number | ADVIA CENTAUR CP |
| Catalog Number | 086-A002-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-12 |