MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-02-01 for DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM 10444802 manufactured by Siemens Healthcare Diagnostics Inc - Brookfield.
[37240948]
Analysis of the instrument and instrument data indicates that the cause for the falsely elevated prog results is unknown. However, the pattern of discrepant repeats on two instruments is suggestive of a sample integrity issue. Per the reagent ifu: complete clot formation should take place before centrifugation. Serum or plasma should be physically separated from cells or separator gel as soon as possible with a maximum limit of 24 hours at room temperature from the time of collection. No process errors or result monitor flags occurred to indicate any mechanical issues. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[37240949]
A discrepant elevated progesterone (prog) result was obtained on a patient sample on the dimension vista instrument. The result was reported to the physician. The sample was later repeated and lower results were obtained and reported. It is unknown if patient treatment was altered or prescribed on the basis of the discrepant elevated progesterone (prog) result. There was no report of adverse health consequences as a result of the discrepant elevated progesterone (prog) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00053 |
| MDR Report Key | 5402104 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-01 |
| Date of Report | 2016-01-08 |
| Date of Event | 2016-01-04 |
| Date Mfgr Received | 2016-01-09 |
| Device Manufacturer Date | 2011-12-27 |
| Date Added to Maude | 2016-02-01 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2016-02-01 |
| Model Number | DIMENSION VISTA |
| Catalog Number | 10444802 |
| 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 | 2016-02-01 |
| Model Number | DIMENSION VISTA |
| Catalog Number | 10444802 |
| 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 | 2016-02-01 |