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 2016-03-03 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[39644281]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluating the instrument, the cse performed a total service call. The cse discovered intermittent and inconsistent dispense of acid from the acid pump assembly. The acid pump assembly was replaced and pump calibrations were verified. The cse performed the dry wet water, wet wash 1 tests. The cse calibrated the method and ran all quality controls, resulting within range. A siemens headquarter support center (hsc) specialist evaluated the event data. Hsc concluded that accurate addition of 300 ul of acid fluid into the cuvette during sampling is critical in the measurement of patient results. If acid was dispensing inconsistently it could have been a contributing factor in the erratic results that were observed. The cause of the discordant ca 27. 29 results on two patient samples was a malfunction of the acid pump assembly. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[39644282]
Discordant, falsely low cancer antigen 27. 29 (ca 27. 29) results were obtained on one replicate when tested in duplicate on two patient samples on an advia centaur xp instrument. The low results obtained on the first replicates were reported to the physician(s). The results of the second replicates were reported as corrected. There are no known reports of patient adverse health consequences due to the discordant ca 27. 29 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00111 |
| MDR Report Key | 5477873 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-03 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-02-05 |
| Date Mfgr Received | 2016-02-05 |
| Device Manufacturer Date | 2008-08-21 |
| Date Added to Maude | 2016-03-03 |
| 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 | MS. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, CO., DUBLIN EL, |
| Manufacturer Country | SZ |
| 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 | 2016-03-03 |
| 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 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-03-03 |
| 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 | 2016-03-03 |