MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-02-04 for CENTRALINK DATA MANAGEMENT SYSTEM manufactured by Siemens Healthcare Diagnostics Inc..
[14881920]
A centralink data management system incorrectly matched a thyroid stimulating hormone (tsh) result obtained on a previous patient's sample to a sample from a different patient. The samples had the same sample identification numbers (sids), but the data from the previous patient should have been purged from the centralink data management system. It is unknown if the previous patient's tsh result was reported to the physician(s). The tsh result for the current patient's sample was located and was lower than the previous patient's result. There are no known reports of patient intervention or adverse health consequences due to a tsh result from a previous patient sample being associated with a current patient sample.
Patient Sequence No: 1, Text Type: D, B5
[15432120]
The customer contacted the siemens customer care center (ccc). The customer reuses sids each month. The centralink data management system is configured to purge data from previously run samples every twenty-one days. The previous sample run with sid (b)(6) had been processed on (b)(6) 2014. During a review of the instrument data, it was discovered that there was a creation date of (b)(6) 2015 for samples aspirated on (b)(6) 2014 and therefore had not been purged because they had not reached twenty-one days from the creation date. Siemens healthcare diagnostics, inc. Is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[34164803]
The initial mdr 2432235-2015-00057 was filed on february 4, 2015. Corrected data: the initial mdr states "siemens healthcare diagnostics, inc is investigating this issue. " siemens could not further investigate the issue because the samples had reached twenty-one days before the log files were requested and therefore had been purged. The cause of a tsh result obtained on a previous patient's sample being matched with a different patient's sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00057 |
| MDR Report Key | 4484355 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-10 |
| Date of Event | 2015-01-10 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2015-03-09 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRALINK DATA MANAGEMENT SYSTEM |
| Generic Name | DATA MANAGEMENT SYSTEM |
| Product Code | NSX |
| Date Received | 2015-02-04 |
| Model Number | CENTRALINK DATA MANAGEMENT SYSTEM |
| 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 | 2015-02-04 |