MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-02 for SIEMENS VISTA 1500 630414949741 manufactured by Siemen Healthcare Diagnostics Inc..
[61512074]
The vista lab machine was resulting sodium and potassium levels as low. There was a 20 unit dip in results. The lab tech had noticed some trending of low lab levels and reran the results. He reported these to the physicians. Siemen was contacted and came to service the machine. They found that there was a int clogged drain. This was fixed and then was functioning properly. All lab results that erroneously reported were caught with the exception of this pt. The erroneous results had been reported to the doctor earlier during the day and when the erroneously results were discovered they were reran around 1700. The test resulted out after clinic hours and the lab department attempted to reach the doctor but were unsuccessful. On (b)(6) 2016, risk was notified that the pt had been admitted the night before for low sodium and potassium levels and had been treated for these results. The pt was discharged home on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6145815 |
| MDR Report Key | 6145815 |
| Date Received | 2016-12-02 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-11-03 |
| Date Facility Aware | 2016-11-03 |
| Report Date | 2016-11-16 |
| Date Reported to FDA | 2016-11-16 |
| Date Reported to Mfgr | 2016-11-16 |
| Date Added to Maude | 2016-12-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SIEMENS VISTA 1500 |
| Generic Name | VISTA 1500 |
| Product Code | JHY |
| Date Received | 2016-12-02 |
| Model Number | 630414949741 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMEN HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-12-02 |