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 2016-12-13 for DIMENSION VISTA? DIMENSION VISTA 1500 DOMESTIC SNM10444801 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[62340154]
The customer contacted the siemens customer care center (ccc) and allowed remote access. The issue was resolved with repeat testing of the same sample. Lower results within physician expectations were obtained within several hours of the original result both from the original tube and after additional centrifugation. Quality control results were within range on the day of the event. The cause of the discordant elevated igg result is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[62340155]
A discordant, falsely elevated immunoglobulin g (igg) result was obtained on one patient sample on a dimension vista1500 instrument. The discordant result was reported to the physician, who questioned the result. The same sample was repeated on the same instrument, resulting lower. The corrected result was reported to the physician. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated igg result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00512 |
| MDR Report Key | 6171892 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-13 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-11-18 |
| Date Mfgr Received | 2016-11-18 |
| Device Manufacturer Date | 2008-08-11 |
| Date Added to Maude | 2016-12-13 |
| 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 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 1336181 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? 1500 SYSTEM |
| Product Code | CFQ |
| Date Received | 2016-12-13 |
| Model Number | DIMENSION VISTA 1500 DOMESTIC |
| Catalog Number | SNM10444801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? 1500 SYSTEM |
| Product Code | JJE |
| Date Received | 2016-12-13 |
| Model Number | DIMENSION VISTA 1500 DOMESTIC |
| Catalog Number | SNM10444801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-13 |