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 2017-10-19 for DIMENSION VISTA? K800A SMN 10484429 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[90665081]
The customer contacted the siemens healthcare diagnostics customer care center about the discordant high plasma potassium result. The cause of the discordant high plasma potassium result is unknown. According to customer's clinical specialist, the increase in k result is known as pseudohyperkalemia due to the patient's high white cell count. Per the customer clinical specialist, the 2. 8 mmol/l serum result is the most accurate result and was then reported. The customer declined troubleshooting assistance from siemens. Siemens headquarters support center (hsc) concluded their investigation of the incident. No product problem has been identified. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[90665082]
A discordant high potassium (k) result was obtained on a plasma sample on the dimension vista 1500 system. The patient plasma result was not reported to the physician. A serum sample from the same draw was run on the same day on the same dimension vista instrument and a lower result was obtained and it was reported. There are no known reports of patient intervention or adverse health consequences due to the discordant high plasma potassium (k) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00753 |
| MDR Report Key | 6963378 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-09-26 |
| Device Manufacturer Date | 2017-04-24 |
| Date Added to Maude | 2017-10-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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 - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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 | 2017-10-19 |
| Catalog Number | K800A SMN 10484429 |
| Lot Number | 7DD898 |
| Device Expiration Date | 2017-10-21 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |