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 2018-09-28 for DIMENSION VISTA? K800A SMN 10484429 manufactured by Siemens Healthcare Diagnostics Inc..
[122172650]
Mdr 2517506-2018-00555 was also filed for the same event. The customer contacted the siemens customer care center (ccc) and reported that a depressed patient potassium result obtained on the dimension vista system was questioned by the physician. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[122172651]
A discordant depressed potassium (k) result was obtained on a patient serum sample on the dimension vista 500 system. This result was reported to the physician who questioned the result. A redraw sample was drawn later the same day and a higher result was obtained in agreement with earlier results at an alternate facility. There are no known reports of patient intervention or adverse health consequences due to the discordant depressed potassium result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00556 |
| MDR Report Key | 7920012 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-28 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-09-06 |
| Date Mfgr Received | 2018-10-04 |
| Device Manufacturer Date | 2018-04-16 |
| Date Added to Maude | 2018-09-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? V-LYTE? INTEGRATED MULTISENSOR NA+ K+ CL- |
| Product Code | CEM |
| Date Received | 2018-09-28 |
| Catalog Number | K800A SMN 10484429 |
| Lot Number | 8DD845 |
| Device Expiration Date | 2018-10-13 |
| 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 | 2018-09-28 |