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 2017-05-12 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[75049037]
The customer contacted the siemens customer care center (ccc). The ccc specialist offered to dispatch the service at the customer site, however, the customer declined the service due to an ongoing issue. The hsc specialist stated that an extensive maintenance has been performed on the instrument during the previous service visits, however, the issue has still not resolved. The instrument will be replaced. The cause of the discordant, falsely low ucfp result on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
[75049038]
A discordant, falsely low urinary/cerebrospinal fluid protein (ucfp) result was obtained on one patient sample on a dimension vista 500 instrument. The discordant result was not reported to the physician(s). The sample was repeated on the same instrument and on an alternate dimension vista instrument, resulting higher than the initial result. The result obtained on the alternate dimension vista instrument was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low ucfp result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00482 |
| MDR Report Key | 6563683 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-12 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2016-01-19 |
| Date Added to Maude | 2017-05-12 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION #: 1226181 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGQ |
| Date Received | 2017-05-12 |
| Model Number | DIMENSION VISTA 500 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-12 |
| Model Number | DIMENSION VISTA 500 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-12 |