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..
[83230107]
The customer contacted the siemens technical support center (tsc) to report the discordant carbon dioxide (co2) results. The tsc ran service methods and found sample arm 3 (s3) and reagent arm 5 (r5) mixer faulty. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse replaced metering pump for s3, s3 and r5 mixer. The cse ran service methods and all were within specifications. The cse ran quality control (qc), which was in range. The cause of the discordant carbon dioxide results 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
[83230108]
Discordant, falsely low carbon dioxide (co2) results were obtained on patient samples on a dimension vista 1500 instrument. The discordant results were not reported to the physician(s). The same samples were repeated on the same instrument, and recovered higher. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant co2 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00661 |
| MDR Report Key | 6802421 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-11-19 |
| 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 |