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 2017-10-04 for DIMENSION VISTA? SMN10284473 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[88234474]
Siemens is investigating the incident.
Patient Sequence No: 1, Text Type: N, H10
[88234475]
A discordant falsely depressed vancomycin (vanc) result was obtained on a pediatric patient sample on the dimension vista 500 instrument. The result was reported to the physician who questioned the result. The same sample was run on the same instrument and a low result was obtained which was higher than the original result. The same sample was tested again on an alternate dimension vista instrument and a higher result was obtained. The physician ordered a second draw to be tested on the same instrument thirty minutes after the original low result and a higher result was obtained which confirmed the high result obtained from the original sample. A corrected report was issued for the higher result obtained from the original sample which was in line with the expected result from the dose administered. There are no reports of adverse health consequences due to the discordant falsely depressed vanc result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00740 |
| MDR Report Key | 6914449 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-04 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2011-08-18 |
| Date Added to Maude | 2017-10-04 |
| 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 |
| 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? 500 SYSTEM |
| Product Code | LEH |
| Date Received | 2017-10-04 |
| Catalog Number | SMN10284473 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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? 500 SYSTEM |
| Product Code | JJE |
| Date Received | 2017-10-04 |
| Catalog Number | SMN10284473 |
| Operator | HEALTH PROFESSIONAL |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-04 |