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 2017-02-02 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[66458296]
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 range at the time of the event. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[66458297]
A discordant, falsely elevated lactate dehydrogenase result was obtained on a patient sample on a dimension vista 1500 instrument. The initial result was released to the physician(s). The customer repeated the same sample on the same instrument, resulting lower. A corrected report was issued 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
[73913306]
The initial mdr 2517506-2017-00129 was filed on february 02, 2017. Additional information (03/21/2017): a siemens headquarters support center (hsc) reviewed the event. Hsc found multiple e111: h interference errors on multiple samples. A review of the customer's quality control (qc) showed that it was within range at the time of the event. Hsc stated that lactate dehydrogenase is very sensitive to sample handling, there can be platelets and cellular debris which can cause erroneous results. 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
| Report Number | 2517506-2017-00129 |
| MDR Report Key | 6298935 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-02 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-03-21 |
| Device Manufacturer Date | 2012-11-16 |
| Date Added to Maude | 2017-02-02 |
| 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 | 2017-02-02 |
| 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 | 2017-02-02 |
| 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 | 2017-02-02 |