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 2017-04-20 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diaganostics Inc..
[73362148]
The customer ran quality control (qc) on both dimension vista instruments following the event, which resulted satisfactory. The customer also performed a five patient sample comparison with the alternate dimension vista instrument, and results were comparable. The customer then contacted the siemens technical support center (tsc). The tsc specialist dispatched a siemens customer service engineer (cse) to the customer site. After evaluating the instrument, the cse replaced the aliquot drain. The customer ran qc, resulting satisfactory. The cause of the discordant, falsely low ucfp results 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
[73362149]
Discordant, falsely low urinary cerebrospinal fluid protein (ucfp) results were obtained on a patient sample on a dimension vista 1500 instrument. The discordant results were not reported to the physician(s). The sample was repeated four times, resulting the same. The sample was then repeated twice on an alternate dimension vista instrument, resulting higher. It is unknown if the alternate instrument results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low ucfp results.
Patient Sequence No: 1, Text Type: D, B5
[75944336]
The initial mdr 2517506-2017-00400 was filed on april 20, 2017. Additional information received (05/11/2017): a siemens headquarter support center (hsc) specialist reviewed the data and determined the cause of the discordant, falsely low ucfp is attributed to the aliquot drain. The issue was resolved with the replacement of the aliquot drain. 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 | 2517506-2017-00400 |
| MDR Report Key | 6508645 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-20 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2008-09-20 |
| Date Added to Maude | 2017-04-20 |
| 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 | MS. 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 | REGISTRATION NUMBER: 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 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGQ |
| Date Received | 2017-04-20 |
| Model Number | DIMENSION VISTA 1500 |
| 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 DIAGANOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-20 |
| Model Number | DIMENSION VISTA 1500 |
| 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 DIAGANOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |