MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-28 for VERSACELL SAMPLE MANAGEMENT SYSTEM manufactured by Siemens Healthcare Diagnostics Inc..
[60995757]
The customer contacted the siemens customer care center (ccc). Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[60995758]
The operator of a versacell sample management system reported that patient samples were found in the wrong locations on the system. The customer looked up patient sample (b)(6). Versacell indicated that sample was in position 488 b2, however, sample (b)(6) was located in that position. When sample (b)(6) was queried, versacell returned a different location of 469 a5. There are no reports of patient intervention or adverse health consequences due to the incorrect location of patient samples.
Patient Sequence No: 1, Text Type: D, B5
[63930762]
The initial mdr 2247117-2016-00084 was filed on november 28th, 2016. Additional information (11/28/2016): a siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse verified robot alignments, bar code reader, and pick and place. The issue reported could not be duplicated. Upon follow up, the customer stated they have not had any additional errors. The cause of incorrect location of patient samples on the instrument 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
| Report Number | 2247117-2016-00084 |
| MDR Report Key | 6130232 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-28 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-11-28 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| 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 | CLINICAL CHEMISTRY GENERAL PURPOSE LABORATORY EQUIPMENT |
| Product Code | CGJ |
| Date Received | 2016-11-28 |
| Model Number | VERSACELL SAMPLE MANAGEMENT SYSTEM |
| 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 | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-28 |