MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-08 for VERSACELL SAMPLE MANAGEMENT SYSTEM 030102 manufactured by Siemens Healthcare Diagnostics Inc..
[19021827]
Three patient sample tubes were dropped by a versacell sample management system while being transferred to an immulite instrument for testing. The samples spilled and were cleaned by the laboratory staff, who wore personal protective equipment. The samples could not be processed by the instrument and new samples had to be obtained from the patients. The spilled contents from the dropped sample tubes did not contaminate any other samples scheduled for testing. There are no known reports of patient intervention or adverse health consequences due to the sample tubes being dropped by the versacell sample management system prior to being sampled by the instrument.
Patient Sequence No: 1, Text Type: D, B5
[19049354]
The customer contacted the siemens customer care center (ccc). During troubleshooting with the customer, it was determined that the versacell sample management system grippers appeared to be working as expected. There were no obstructions and all o-rings were in place. A siemens customer service engineer (cse) was dispatched to the customer site. The cse replaced the x-direction server motor printed circuit board and adjusted the arm alignment. The cause of the dropped sample tubes is unknown. The versacell sample management system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2014-00025 |
| MDR Report Key | 3801407 |
| Report Source | 05,06 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-04-15 |
| Date of Event | 2014-04-15 |
| Date Mfgr Received | 2014-04-15 |
| Date Added to Maude | 2014-06-25 |
| 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 INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSACELL SAMPLE MANAGEMENT SYSTEM |
| Generic Name | SAMPLE MANAGEMENT SYSTEM |
| Product Code | DGC |
| Date Received | 2014-05-08 |
| Model Number | VERSACELL SAMPLE MANAGEMENT SYSTEM |
| Catalog Number | 030102 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-08 |