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 2016-11-28 for VERSACELL SAMPLE MANAGEMENT SYSTEM manufactured by Siemens Healthcare Diagnostics Inc..
[60994484]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse adjusted the barcode position and verified racks and tubes were read. The cause of the barcode mismatch is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[60994585]
The operator of a versacell sample management system reported barcode mismatching on the system. When the versacell scans a small or aliquot tube, it occasionally scans the large tube located behind the smaller tube. The verscell arm then picks up the larger tube and a duplicate barcode message is obtained. The customer stated there were no results reported which were questioned or corrected reports issued due to the barcode mismatch. There are no reports of patient intervention or adverse health consequences due to the barcode mismatch.
Patient Sequence No: 1, Text Type: D, B5
[64469327]
The initial mdr 2247117-2016-00083 was filed on november 28th, 2016. Additional information (12/15/2016): a siemens headquarter support center (hsc) specialist evaluated the service data related to the event. The beams on the barcode reader assembly were adjusted to the to the right length or width during service so as not to overlap when reading a sample tube. There were no further incidents since service was performed. 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 | 2247117-2016-00083 |
| MDR Report Key | 6129894 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-28 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-11-01 |
| Date Mfgr Received | 2016-12-15 |
| 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 |