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 2017-04-07 for VERSACELL SAMPLE MANAGEMENT SYSTEM VERSACELL X3 manufactured by Siemens Healthcare Diagnostics Inc..
[72502293]
The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data provided. The ccc found the customer's quality control (qc) was in at the time of the event. The customer stated no errors were found in the error log of the instrument. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[72502294]
Discordant sodium and chloride results were obtained on four patient samples, on an versacell x3 sample management system. The customer repeated the same samples by front loading the samples in their dimension instrument. The repeated samples resulted within the expected clinical range. The repeat results were released to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, sodium and chloride results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2017-00047 |
| MDR Report Key | 6474322 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-07 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-03-11 |
| Date Mfgr Received | 2017-06-27 |
| Date Added to Maude | 2017-04-07 |
| 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 | 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 | REGISTRATION #: 2247117 62 FLANDERS BARTLEY ROAD |
| 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 | JGS |
| Date Received | 2017-04-07 |
| Model Number | VERSACELL X3 |
| 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 |
| Brand Name | VERSACELL SAMPLE MANAGEMENT SYSTEM |
| Generic Name | CLINICAL CHEMISTRY GENERAL PURPOSE LABORATORY EQUIPMENT |
| Product Code | DGC |
| Date Received | 2017-04-07 |
| Model Number | VERSACELL X3 |
| 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 | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-07 |