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 2017-10-19 for DIMENSION VISTA? 10444801 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[90655631]
Siemens healthcare diagnostics concluded their investigation and is unable to determine the cause of the discordant elevated total prostate specific antigen (tpsa) result obtained on a patient sample on the dimension vista system as the data was unable to be obtained from the event date. No repeat testing was performed on the original sample. Quality control was within specification during testing. The siemens customer service engineer (cse) was dispatched to the site. The cse performed the following repairs; replaced aliquot probe after a failed alignment, performed aliquot probe auto-align, primed fluids, replaced body probe assembly, performed reagent shuttle 2 auto-align, replaced aliquot probe holder assay due to a damaged level sense connector. Cse also inspected the imt std a rotary valve hold rates and confirmed the rates to be stable and in normal range. After instrument repair, the instrument was fully functioning and there were no further issues. The cause for the falsely discordant elevated tpsa result is unknown. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[90655632]
A discordant elevated total prostate specific antigen (tpsa) result was obtained on a patient sample on the dimension vista system. The result was reported to the physician and was not questioned. No corrected report was issued. A new sample was drawn at a later date and a lower result was obtained. There are no reports of patient intervention or adverse health consequences due to the discordant elevated tpsa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00782 |
| MDR Report Key | 6963279 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-19 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2017-10-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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- BROOKFIELD |
| Manufacturer Street | REGISTRATION NUMBER 1226181 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? |
| Generic Name | DIMENSION VISTA? SYSTEM 1500 |
| Product Code | LTJ |
| Date Received | 2017-10-19 |
| Catalog Number | 10444801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? SYSTEM 1500 |
| Product Code | JJE |
| Date Received | 2017-10-19 |
| Catalog Number | 10444801 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-19 |