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 2016-05-20 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[45628278]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse performed a total service call, system decontamination and verified that the instrument was functioning properly. The customer ran quality controls and patient samples, which were acceptable. During a follow-up visit, the cse replaced the rotating piston acid and base wash pump, positive displacement pump, valve manifold, and luminometer. The cse calibrated all the assays and ran quality controls, which were acceptable. The cause of the discordant, falsely elevated total hcg result on one patient sample 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
[45628279]
A discordant, falsely elevated total human chorionic gonadotropin (total hcg) result was obtained on one patient sample upon repeat testing on an advia centaur cp instrument. The sample was initially run on the same instrument, resulting lower. The discordant result was not reported to the physician(s). The customer repeated the sample on a dimension instrument, resulting similar to the initial result obtained on the advia centaur cp instrument. The initial result from the advia centaur cp instrument was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total hcg result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00260 |
| MDR Report Key | 5669884 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-20 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-04-26 |
| Date Added to Maude | 2016-05-20 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | STRATEC BIOMEDICAL SWITZERLAND AG |
| Manufacturer Street | REGISTRATION #: 3008494306 GEWERBESTRASSE 6 |
| Manufacturer City | NEUHAUSEN AM RHEINFALL, 8212 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8212 |
| 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 | NAL |
| Date Received | 2016-05-20 |
| Model Number | ADVIA CENTAUR CP |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-20 |