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 2018-04-27 for DIMENSION VISTA? K1137 SMN 10445163 manufactured by Siemens Healthcare Diagnostics Inc..
[106853816]
The customer contacted siemens customer care center (ccc) and reported that discordant, falsely depressed carbon dioxide (co2) results were obtained on the dimension vista 1500 system on one patient. Siemens headquarters support center (hsc) has completed their evaluation of the event and the information provided. The cause is unknown. Hsc review of the instrument data for this event indicates qc is within range with no evidence of outliers to suggest an instrument problem. Hsc review of water processing module (wpm) properties indicated no water quality issues were observed that could contribute to a falsely low co2 result. No consumable product problem has been identified. The device is operating per specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[106853817]
A discordant, falsely depressed carbon dioxide (co2) result was obtained on a patient venous sample on two dimension vista 1500 systems. The results were reported to the physician who questioned the result. An arterial blood sample from the same patient was tested by an alternate non-siemens methodology (blood gas analyzer) and a higher result was obtained. The original venous sample was repeated on the alternate methodology and the higher result was obtained. A corrected report was issued. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed co2 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00262 |
| MDR Report Key | 7469870 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-04-27 |
| 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? CO2 CARBON DIOXIDE FLEX? REAGENT CARTRIDGE |
| Product Code | KHS |
| Date Received | 2018-04-27 |
| Catalog Number | K1137 SMN 10445163 |
| Lot Number | 17240BC |
| Device Expiration Date | 2018-08-28 |
| 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 | 2018-04-27 |