MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-08-19 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[52737123]
A customer contacted a siemens customer care center (ccc) specialist. The ccc inquired about calibration and quality control (qc). The customer stated that the calibration and qc were valid and in range. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[52737124]
Discordant, falsely depressed digitoxin (dgtn) results were obtained on a patient sample on an advia centaur xp instrument. The initial result was reported out to the physician(s), who questioned the result. The same sample was re-tested on the same advia centaur xp instrument, resulting lower. The customer then sent the sample to another lab to test it on an alternate instrument, resulting within the therapeutic range. Both of the repeat results were reported out to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed digitoxin results.
Patient Sequence No: 1, Text Type: D, B5
[55340838]
The initial mdr 2432235-2016-00491 was filed on august 19, 2016. Additional information was received on 08/17/2016: a siemens technical applications specialist (tas) tested a sample provided by the customer. The tas found that the advia centaur xp results were lower than the dimension vista's results. A siemens headquarters support center (hsc) specialist reviewed the event. Hsc stated that a siemens customer service engineer (cse) performed a total system check. The cse checked the luminometer dark count, which passed. The cse then checked sample probe, reagent 1 dispense and aspirate, reagent probe 1 alignment, reagent 1 wash station, acid and base dispense, was dispense aspiration probe (for leaks) and all parts were good. The cse cleaned the cover of the ancillary/sample probe. Hsc stated the results were not reproducible. The cause of the discordant falsely depressed digitoxin 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
[55340839]
A siemens technical applications specialist (tas) performed troubleshooting with a sample provided by the customer for digitoxin (dgtn) and compared the advia centaur xp instrument with two dimension vista instruments. The tas found a low bias from the advia centaur xp instrument. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed digitoxin results.
Patient Sequence No: 1, Text Type: D, B5
[61117046]
The initial mdr 2432235-2016-00491 was filed on august 19, 2016. Follow-up #1 (mdr 2432235-2016-00491_s1) was filed on september 1, 2016. Additional information (10/21/2016): a siemens' technical operations specialist reviewed the quality control (qc) data provided from november of 2014 to june 2016. The data provided showed the assay is performing as expected. All three levels of the qc tested, were within range. Values obtained with different methods cannot be used interchangeably due to method differences and levels of cross-reactivity with metabolites. 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 | 2432235-2016-00491 |
| MDR Report Key | 5890924 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-19 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-05-25 |
| Date Mfgr Received | 2016-10-21 |
| Device Manufacturer Date | 2011-04-11 |
| Date Added to Maude | 2016-08-19 |
| 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 | MR TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 CHAPEL LANE |
| Manufacturer City | 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KXT |
| Date Received | 2016-08-19 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 XP |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-08-19 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-08-19 |