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 2017-10-09 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc..
[89955661]
The customer contacted a siemens customer care center (ccc) and stated that their quality controls were within specification. The ccc specialist dialed into the system remotely and determined that there was a process error for the aliquot probe and the container bottom was not found. The ccc specialist ran a quick check, which passed. The aliquot probe was replaced and aligned. The ccc specialist stated that the issue was resolved by replacing the aliquot probe. The instrument is performing within manufacturing specifications. No further evaluation if device is required.
Patient Sequence No: 1, Text Type: N, H10
[89955662]
A discordant, falsely low vancomycin result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the pharmacist, who questioned it. The sample was repeated on an alternate dimension vista instrument and on the original instrument, resulting higher both times. The corrected result from the alternate dimension vista instrument was reported. There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low vancomycin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00759 |
| MDR Report Key | 6929608 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-14 |
| Device Manufacturer Date | 2017-04-03 |
| Date Added to Maude | 2017-10-09 |
| 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 | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION #: 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 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LEH |
| Date Received | 2017-10-09 |
| Model Number | DIMENSION VISTA 1500 |
| 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. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-10-09 |
| Model Number | DIMENSION VISTA 1500 |
| 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. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-09 |