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 2015-09-25 for ADVIA CENTAUR CP manufactured by Siemens Healthcare Diagnostics Inc..
[26780327]
A siemens customer service engineer (cse) was dispatched to the customer. After evaluation of the instrument and instrument data, the cse adjusted aspiration probe 2 as it was too high and was not fixed to the vertical rack. The cse checked the acid and base dispense volumes, cleaned the luminometer, and checked the wash station, injector, distribution volume, and connectors. The cse replaced the wash 1 pump due to a crack. Quality controls were within range. The cause of the discordant, (b)(6) result is unknown, as repeat testing on the same instrument resulted as expected. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[26780328]
A discordant, (b)(6) antibodies to (b)(6) surface antigen ((b)(6)) result was obtained on one patient sample on an advia centaur cp instrument. The discordant result was reported to the physician(s). Two weeks later, a new sample was obtained from the patient and tested on the same instrument, resulting (b)(6). The customer then centrifuged and repeated the original sample on the same instrument, and the result was also (b)(6). The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant,(b)(6) result.
Patient Sequence No: 1, Text Type: D, B5
[32245493]
The initial mdr 2432235-2015-00414 was filed on september 25, 2015. Additional information (10/23/2015): in an investigation conducted by siemens healthcare it has been determined that the wash 1 pump which was replaced is suspected to be the cause of the (b)(6) result. The assessment is based on the wash sequence that is specified for the (b)(6) assay, which requires a three wash sequence to be performed. In this case, the wash 1 pump delivers wash 1 to dispense port 1 and wash displacement port.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00414 |
| MDR Report Key | 5103914 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-25 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-14 |
| Date Mfgr Received | 2015-10-23 |
| Date Added to Maude | 2015-09-25 |
| 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 | 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 | 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 | LOM |
| Date Received | 2015-09-25 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CENTAUR CP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-09-25 |
| Model Number | ADVIA CENTAUR CP |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-25 |