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 2019-02-27 for DIMENSION VISTA? K1137 SMN10445163 manufactured by Siemens Healthcare Diagnostics Inc.
[137285207]
Mdr 2517506-2019-00079 was also filed for the same event. The customer contacted the siemens customer care center (ccc) and reported that a discordant, falsely depressed carbon dioxide (co2) result was obtained on the dimension vista 1500 system s/n (b)(4). Siemens headquarters support center (hsc) completed the investigation of the event. Hsc has reviewed the information provided and the instrument data. Quality control data was within conformance. No process errors were observed at the time of the reported event. Hsc review of the information could potentially suggest the low co2 result is patient sample specific due to a condition of metabolic acidosis for this patient resulting in a decreased bicarbonate concentration and subsequent decreased total co2 measurement. There is no evidence of a product nonconformance. The cause of the event is unknown. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[137285208]
A discordant falsely depressed carbon dioxide (co2) patient result was obtained on a dimension vista 1500 system. The initial result was not reported to the physician(s). A new patient sample was processed on a non-siemens alternate methodology and a higher result was obtained. There are no reports of patient intervention or adverse health consequence due to the discordant falsely depressed co2 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2019-00078 |
| MDR Report Key | 8374162 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-02-04 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2019-02-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 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 P.O. BOS 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 | 2019-02-27 |
| Catalog Number | K1137 SMN10445163 |
| Lot Number | 18204BC |
| 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 P.O. BOS 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-27 |