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 2018-03-14 for DIMENSION VISTA? K800A SMN10484429 manufactured by Siemens Healthcare Diagnostics Inc..
[102453979]
Mdr 2517506-2018-00175 was also filed for the same customer inquiry. The customer contacted the siemens customer care center for the discordant, imprecise (k) results on the dimension vista instrument. Siemens headquarters support center (hsc) has completed the investigation of the incident. Hsc evaluated the data provided. The cause of the discrepant imprecise k results cannot be confirmed; however, it is specific to the patient. No product problem has been identified. Qc was within range at the time of testing. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[102453980]
Discordant, imprecise potassium (k) results were obtained on a patient sample on the dimension vista 500 instrument. There are no reports of patient intervention or adverse health consequences due to the discordant, imprecise potassium results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00177 |
| MDR Report Key | 7339706 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-14 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-02-15 |
| Device Manufacturer Date | 2017-11-06 |
| Date Added to Maude | 2018-03-14 |
| 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 | 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 | 2018-03-14 |
| Catalog Number | K800A SMN10484429 |
| Lot Number | 7LD824 |
| Device Expiration Date | 2018-05-05 |
| 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 | 2018-03-14 |