MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-31 for ADVIA CENTAUR XP 078-A011-03 manufactured by Siemens Healthcare Diagnostics Inc..
[4190257]
The operator of an advia centaur xp instrument ran multiple patient samples being tested for (b)(6). Upon review of results after the run, the operator discovered that one patient's sample identification (sid) number was incorrectly matched with the name of a different patient whose sample had also been tested in the run. The other patient's sid had been correctly matched with their name. The issue was identified prior to incorrect results being reported to the physician(s) for one patient. There are no known reports of patient intervention or adverse health consequences due to one patient's sid being incorrectly matched with the name of a different patient.
Patient Sequence No: 1, Text Type: D, B5
[11712372]
A siemens global product support (gps) specialist reviewed the instrument data and did not find an instrument malfunction. The customer stated that their laboratory information system (lis), which is not a siemens product, had produced an error for an unknown record type during the run. The cause of one patient's sid being incorrectly matched with the name of a different patient is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[37080594]
The initial mdr 2432235-2014-00156 was filed on january 31, 2014. Additional information (08/12/2014): siemens healthcare diagnostics has identified an issue with patient demographic information sent to the lis from the advia centaur/advia centaur xp immunoassay systems. Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the lis is merged with the next order. This issue can occur when the lis data buffer on the advia centaur system becomes full and a particular character is found in the last five locations in the lis data buffer. In this case, the incorrect patient demographic information will be transmitted to the lis and will be displayed on the advia centaur user interface and instrument generated printed reports. Urgent medical device correction (umdc) 10819176 entitled "advia centaur/advia centaur xp incorrect patient demographic information" was sent to customers in the united states and urgent field safety notice (ufsn) 10819175 entitled "advia centaur/advia centaur xp incorrect patient demographic information" was sent to customers outside the united states in august 2014. The umdc and ufsn describe the issue and provide actions for customers to take if their instrument is interfaced to an lis system that transmits patient demographics with each order. Corrected information: the product code in the initial mdr was listed as jje. The correct product code is moi. The 510(k) number in the initial mdr was listed as k041133. The correct 510(k) number is k971418. This information has been changed, respectively.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00156 |
| MDR Report Key | 3602640 |
| Report Source | 05,06 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-06 |
| Date of Event | 2014-01-03 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-04-24 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE REGISTRATION NUMBER: 8020888 |
| Manufacturer City | DUBLIN, SWORDS |
| Manufacturer Country | EI |
| Single Use | 0 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-08/20/14-006-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | NHS |
| Date Received | 2014-01-31 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A011-03 |
| 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 | 2014-01-31 |