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 2018-05-11 for DIMENSION VISTA? K4086 SMN 10445128 manufactured by Siemens Healthcare Diagnostics Inc..
[107975607]
The customer contacted the siemens customer care center (ccc) and reported that a discordant, falsely depressed vanc patient result was obtained on the dimension vista 500 system. The ccc representative reviewed the vista instrument data logs and found no process errors or any other related issues. Siemens headquarters support center (hsc) has completed their evaluation of the event and information provided. Vanc quality control (qc) recovery at the time of this event was within acceptable ranges. No product nonconformance with the instrument or reagent was identified. The device is operating within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[107975608]
A discordant, falsely depressed vancomycin (vanc) result was obtained on a patient sample on the dimension vista 500 system. The result was reported to the physician(s). The same sample was repeated on the same instrument and on an alternate vista instrument and a higher result was obtained. A corrected result was issued. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed vancomycin (vanc) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00296 |
| MDR Report Key | 7506193 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-04-16 |
| Device Manufacturer Date | 2017-10-27 |
| Date Added to Maude | 2018-05-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 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. |
| Manufacturer Street | 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? VANC VANCOMYCIN FLEX? REAGENT CARTRIDGE |
| Product Code | LEH |
| Date Received | 2018-05-11 |
| Catalog Number | K4086 SMN 10445128 |
| Lot Number | 17299AC |
| Device Expiration Date | 2018-10-26 |
| 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 | 2018-05-11 |