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 2017-03-24 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[70874741]
The customer contacted a siemens regional service center (rsc) specialist. The customer stated after the initial results they performed calibration. The repeat results were within the expected range. The customer stated that after this, they stated to show depressed results. Rsc performed troubleshooting with the customer. The customer replaced sample probe 1, reagent probe 1 and reagent probe 2. The customer cleaned the drains. The cause of the discordant, falsely elevated lactate dehydrogenase result 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
[70874742]
A discordant, falsely elevated lactate dehydrogenase result was obtained on a patient sample on a dimension vista 500 instrument. The initial result was released to the physician(s). The customer performed calibration and repeated the same sample on the same dimension vista instrument, resulting within the patient's expected clinical range. The customer issued a corrected report to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated lactate dehydrogenase result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00303 |
| MDR Report Key | 6434572 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-02-17 |
| Date Mfgr Received | 2017-02-27 |
| Device Manufacturer Date | 2015-03-12 |
| Date Added to Maude | 2017-03-24 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| 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 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFH |
| Date Received | 2017-03-24 |
| Model Number | DIMENSION VISTA 500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-03-24 |
| Model Number | DIMENSION VISTA 500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-03-24 |