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 2017-11-09 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[92638431]
The customer contacted the siemens customer care center (ccc). Quality controls were within the acceptable range. The ccc specialist reviewed the process error log and found no errors that occurred at the time the patient sample was affected. The customer stated that no other patient samples were affected. The cause for the discordant, falsely elevated k 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
[92638432]
A discordant, falsely elevated potassium (k) result was obtained on a patient sample upon repeat testing on a dimension vista 500 instrument. Multiple sample draws were obtained from the patient and were tested on the same dimension vista instrument. The initial result was lower and the consecutive draws resulted higher than the initial results and lower than the result obtained with the first redraw. The result obtained with the fourth sample draw ((b)(6)) was considered correct and was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated k result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00807 |
| MDR Report Key | 7015189 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-09 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-10-14 |
| Date Mfgr Received | 2017-12-01 |
| Device Manufacturer Date | 2012-12-06 |
| Date Added to Maude | 2017-11-09 |
| 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 | 0 |
| 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 #: 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 | CEM |
| Date Received | 2017-11-09 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-09 |