MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-02 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[5921592]
Discordant cancer antigen 27. 29 (br 27. 29) results were obtained on three patient samples on an advia centaur xp instrument. The discordant results were not reported to the physician(s), as they did not match the patient's clinical histories. The samples were repeated in triplicates on the same instrument, and the customer reported the mean of the results for each patient as the corrected result. There are no reports of patient intervention or adverse health consequences due to the discordant br 27. 29 results.
Patient Sequence No: 1, Text Type: D, B5
[13392506]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse replaced the photo multiplier tube and the base probe. The customer calibrated the instrument and ran quality controls. The cause of the discordant br 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 | 2432235-2015-00274 |
| MDR Report Key | 4813562 |
| Report Source | 05,06 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-05-04 |
| Device Manufacturer Date | 2009-05-29 |
| Date Added to Maude | 2015-06-29 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| 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 XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | MOI |
| Date Received | 2015-06-02 |
| Model Number | ADVIA CENTAUR XP |
| 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 | 2015-06-02 |