MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-06 for DIMENSION VISTA? CLINICAL CHEMISTRY SYSTEM VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc - Brookfield.
[2106584]
A falsely depressed calcium result was obtained on a patient sample. Several other analytes on the same sample were depressed. The results were reported to the physician. A new (redraw) sample was run. A higher result within the normal range was obtained for the calcium and reported. Other analytes were not repeated. No other patient samples were impacted. The patient received a iv infusion based on the original calcium result. There was no report of adverse health consequences as a result of the falsely depressed calcium result.
Patient Sequence No: 1, Text Type: D, B5
[9253648]
Further analysis of the instrument and instrument data indicate that the cause for the falsely depressed calcium result was unknown. An insufficient sample is suspected. A siemens healthcare diagnostics inc. Field service engineer (fse) was dispatched to the site. No malfunctions were detected. The fse performed maintenance. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[17473392]
A falsely depressed calcium result was obtained on a patient sample. The result was reported to the physician. A new (redraw) sample was run. A higher result within the normal range was obtained and reported. The patient received a iv infusion based on the original calcium result. There was no report of adverse health consequences as a result of the falsely depressed calcium result.
Patient Sequence No: 1, Text Type: D, B5
[17655863]
Analysis of the instrument and instrument data indicate that the cause for the falsely depressed calcium result was aliquotter probe maintenance issues. A siemens healthcare diagnostics inc. Field service engineer (fse) was dispatched to the site and performed maintenance procedures. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2011-00033 |
| MDR Report Key | 2041893 |
| Report Source | 05,06 |
| Date Received | 2011-04-06 |
| Date of Report | 2011-03-22 |
| Date of Event | 2011-03-19 |
| Date Mfgr Received | 2011-03-22 |
| Device Manufacturer Date | 2009-10-13 |
| Date Added to Maude | 2011-04-21 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. CAROLYN CHASTAIN |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318789 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD |
| Manufacturer Street | 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? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | JFP |
| Date Received | 2011-04-06 |
| Model Number | VISTA 1500 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 - BROOKFIELD |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-06 |