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 2017-08-17 for DIMENSION VISTA1500 manufactured by Siemens Healthcare Diagnostics Inc..
[83230005]
The customer contacted the siemens customer care center (ccc) to report the discordant carbon dioxide (co2) result. The ccc reviewed the data and noted that the co2 had not been calibrated recently. The ccc checked for process errors and found integrated multi sensor technology (imt) errors. The ccc changed the co2 to a new well and ran quality control (qc), resulting in range. A siemens customer service engineer (cse) was dispatched to the customer's site. The customer was not able to calibrate the co2 method due to an incorrect qc being attached to the calibration. The qc lots attached to the calibration were trial qc's that the customer no longer had in stock. The cse reset the instrument, removed the qc results, and calibrated the co2 method after which qc recovered within range. The cause of the discordant carbon dioxide result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[83230006]
A discordant, falsely high carbon dioxide (co2) result was obtained on one patient sample on a dimension vista 1500 instrument. The discordant result was reported to the physician(s). The same sample was repeated on the same instrument, and recovered lower. The corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant co2 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00658 |
| MDR Report Key | 6802419 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-07-20 |
| Date Mfgr Received | 2017-07-24 |
| Device Manufacturer Date | 2011-11-20 |
| Date Added to Maude | 2017-08-17 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 101 SILVERMINE ROAD REGISTRATION NUMBER: 1226181 |
| 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 VISTA1500 |
| Generic Name | DIMENSION VISTA1500 |
| Product Code | CHS |
| Date Received | 2017-08-17 |
| Model Number | DIMENSION VISTA1500 |
| 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 VISTA1500 |
| Generic Name | DIMENSION VISTA1500 |
| Product Code | JJE |
| Date Received | 2017-08-17 |
| Model Number | DIMENSION VISTA1500 |
| 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 | 2017-08-17 |