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 Diagnostics.
[73380454]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer site. The cse analyzed the instrument by inspecting the reagent pump 1 belts, rails and probe. The sample pump 1 was removed, rebuilt and replaced. The horizontal rail was lubricated. The cse performed verification by running a reagent 1 diagnostics and quick check. The cause of the discordant uric acid result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[73380455]
A discordant falsely elevated uric acid (urca) result was obtained from a dimension vista 1500 instrument. This result was not reported to the physician. A repeat using the same sample was performed on an alternate dimension vista 1500 instrument. The repeat result was reported to the physcian. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated urca result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00414 |
| MDR Report Key | 6508583 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-04-01 |
| Device Manufacturer Date | 2010-02-23 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| 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 1500 |
| Generic Name | DIMENSION VISTA 1500 |
| Product Code | CDH |
| Date Received | 2017-04-20 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 19714 US 19714 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | DIMENSION VISTA 1500 |
| Product Code | JJE |
| Date Received | 2017-04-20 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |