MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-13 for ADVIA CENTAUR 078-A001-08 manufactured by Siemens Healthcare Diagnostics Inc..
[18034916]
Discordant cancer antigen 27. 29 (ca 27. 29) results were obtained on two patient samples on an advia centaur instrument. The initial results were reported to the physician(s). The laboratory manager questioned the results and quality controls were run, resulting out of range. The customer recalibrated the assay, reran quality controls and repeated the samples on the same instrument, and the corrected results were obtained. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant ca 27. 29 results.
Patient Sequence No: 1, Text Type: D, B5
[18119266]
The customer contacted the siemens customer care center (ccc). The customer reported that on january 8th, 2015, quality controls (qc) were out of range. The customer dispatched their own internal service to check the instrument. It is unknown what actions were taken by the service personnel. The following day, discordant results were obtained on the instrument, after which the customer ran quality controls, which were out of range. The customer recalibrated the assay and reran qc, after which the correct results were obtained. On a later date, a siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse discovered a failed 3 way solenoid cleaning valve and bleach in the system. The cse replaced valves 66 and 67, and cleaned the dispense ports on the wash station. Qc were run, resulting within range. The cause of the discordant ca 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
| Report Number | 2432235-2015-00067 |
| MDR Report Key | 4516262 |
| Report Source | 05,06 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-01-18 |
| Date of Event | 2015-01-09 |
| Date Mfgr Received | 2015-01-18 |
| Device Manufacturer Date | 2007-03-05 |
| Date Added to Maude | 2015-03-19 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, CO., DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-02-13 |
| Model Number | ADVIA CENTAUR |
| Catalog Number | 078-A001-08 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-13 |