MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-07-13 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM manufactured by Siemens Healthcare Diagnostics Inc - Brookfield.
[15388635]
Falsely elevated progesterone (prog) results were obtained on patient samples on the dimension vista instrument. The results were reported to the physician. The samples were later questioned and repeated by an alternate siemens methodology (advia centaur) and lower results were obtained concordant with the patient clinical history. Ther is no indication that patient treatment was altered or prescribed on the basis of the initial falsely elevated prog results. There was no report of adverse health consequences as a result of the initial falsely elevated prog results.
Patient Sequence No: 1, Text Type: D, B5
[15479192]
Analysis of the instrument and instrument data indicate that the cause for the falsely elevated prog results is unknown. The issue is under investigation by siemens healthcare diagnostics.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2015-00414 |
| MDR Report Key | 4908925 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-13 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-06-14 |
| Date Mfgr Received | 2015-06-17 |
| Device Manufacturer Date | 2011-10-05 |
| Date Added to Maude | 2015-08-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| 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 | DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM |
| Product Code | JLS |
| Date Received | 2015-07-13 |
| Model Number | DIMENSION VISTA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Brand Name | DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM |
| Generic Name | DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM |
| Product Code | JJE |
| Date Received | 2015-07-13 |
| Model Number | DIMENSION VISTA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2015-07-13 |