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 2018-04-24 for DIMENSION VISTA? K1033A SMN 10872082 manufactured by Siemens Healthcare Diagnostics Inc..
[106391128]
The customer contacted siemens customer care center (ccc) and reported that discordant, falsely depressed creatinine (cre2) results were obtained on the dimension vista 500 system. Siemens headquarters support center (hsc) has completed their evaluation of the incident and the information provided. No product nonconformance with the instrument or reagent was identified. The issue was resolved by replacing the cre2 flex reagent cartridge on the same instrument. The cause is unknown. The device is operating per specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[106391129]
Discordant, falsely depressed creatinine (cre2) results were obtained on patient samples on the dimension vista 500 system. The results were reported to the physician(s). The same samples were repeated on the same instrument or on an alternate vista instrument and higher results were obtained. Corrected results were issued. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed creatinine (cre2) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00276 |
| MDR Report Key | 7454979 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-03-30 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 2017-10-26 |
| Date Added to Maude | 2018-04-24 |
| 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? CRE2 CREATININE FLEX? REAGENT CARTRIDGE |
| Product Code | CGX |
| Date Received | 2018-04-24 |
| Catalog Number | K1033A SMN 10872082 |
| Lot Number | 17299BA |
| 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 | 2018-04-24 |