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 2016-06-07 for ADVIA CENTAUR manufactured by Siemens Healthcare Diagnostics Inc..
[46690154]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. The cse inspected the wash and aspiration operations at the wash manifold. The cse checked the acid and base volume, inspected calibrations of the sample probe, ancillary probe and reagent probes and checked the dispense heights. The cse ran dark counts with cuvettes and performed precision testing. The customer repeated other patient samples and verified that they were all acceptable. The customer stated that the discordant result was an isolated event. The cause of the discordant, falsely low ca 27. 29 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
[46690155]
A discordant, falsely low cancer antigen 27. 29 (ca 27. 29) result was obtained on one patient sample on an advia centaur instrument. The discordant result was reported to the physician(s), who questioned it. The sample was repeated on the same instrument, resulting higher and matching the clinical picture of the patient. The corrected result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low ca 27. 29 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00298 |
| MDR Report Key | 5702892 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-07 |
| Date of Report | 2016-06-07 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-05-12 |
| Date Added to Maude | 2016-06-07 |
| 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 | CHIRON DIAGNOSTICS CORPORATION |
| Manufacturer Street | 132 ARTINO STREET |
| Manufacturer City | OBERLIN OH 440741293 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 440741293 |
| 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 | 2016-06-07 |
| Model Number | ADVIA CENTAUR |
| 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 |
| Brand Name | ADVIA CENTAUR |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-06-07 |
| Model Number | ADVIA CENTAUR |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-07 |