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 2015-09-21 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[26482430]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse checked the probe alignment and found that the sample probe connector was loose. The cse replaced the sample probe and performed sample probe pressure test, which was acceptable. The cse also ran quality controls and patient samples. The cause of the discordant ferritin, folate and vitamin b12 results on multiple samples 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
[26482431]
Discordant ferritin (ferr), folate (fol) and vitamin b12 (vb12) results were obtained on multiple patient samples on an advia centaur xp instrument. The discordant results were not reported to the physician(s). The samples were repeated on the same instrument, resulting different from the initial results. The repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant ferritin, folate and vitamin b12 results.
Patient Sequence No: 1, Text Type: D, B5
[32492758]
The initial mdr 2432235-2015-00411 was filed on september 23, 2015. Additional information (09/15/2015): upon a follow-up visit, a siemens customer service engineer (cse) specialist found microbubbles at the wash manifold line and suspected micro leak at the connectors. The cse replaced the reagent probe 1, the reagent probe 2 and the wash displacement line at the manifold. The cse ran calibrations and quality controls, which were acceptable. A siemens headquarters support center (hsc) specialist reviewed the service report and indicated that the cause of the discordant ferritin, folate and vitamin b12 results on multiple samples was related to a malfunction of the manifold connectors. 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 | 2432235-2015-00411 |
| MDR Report Key | 5091620 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-21 |
| Date of Report | 2015-08-27 |
| Date of Event | 2015-08-27 |
| Date Mfgr Received | 2015-09-15 |
| Device Manufacturer Date | 2008-01-21 |
| Date Added to Maude | 2015-09-21 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, 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 | DBF |
| Date Received | 2015-09-21 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-21 |