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 2015-10-01 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics, Inc..
[27204401]
The customer did not inform siemens about the testosterone result. A siemens customer service engineer (cse) visited the customer site multiple times due to the failures in the daily cleaning procedure (dcp), which were addressed with replacement of all two-way valves in the reagent pump pathway, the fluid global input output bus printed circuit board, a solenoid valve, valves in line with the resuspend dilutor, the wash manifold, acid and dilutor control cable, and cleaning and water valves. The cse also adjusted the base pump and reseated cable connections. The cse verified that the instrument was operational by successfully performing the dcp and running quality controls. This instrument is performing according to specifications. No further evaluation of the device is required. Medwatch (b)(4) was filed with the fda by the customer. Siemens was not made aware of any affected test results until the receipt of medwatch (b)(4), post-marked september 3, 2015. The post-marked date of september 3, 2015 was used as the awareness date for this information, however, siemens received the envelope containing medwatch (b)(4) after that date.
Patient Sequence No: 1, Text Type: N, H10
[27204402]
Testosterone and vitamin d tests were ordered on an advia centaur instrument. A physician questioned a testosterone result that was reported. Quality controls were within range and there was no indication that the test results produced by the instrument were incorrect. It is unknown if there were any patient interventions or adverse health consequences due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2015-00460 |
| MDR Report Key | 5115678 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-01 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-07-21 |
| Date Mfgr Received | 2015-09-03 |
| Device Manufacturer Date | 2014-12-08 |
| Date Added to Maude | 2015-10-01 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE REGISTRATION NUMBER: 8020888 |
| Manufacturer City | DUBLIN, SWORDS |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | CDZ |
| Date Received | 2015-10-01 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-01 |