MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-11-02 for DIMENSION VISTA? DIMENSION VISTA 1500 INTERNATIONAL 10444802 manufactured by Siemens Healthcare Diagnostics Inc- Brookfield.
[59046803]
Analysis of the instrument data provided indicates that the cause for the falsely depressed crp results is user error. The customer contacted the siemens customer care center to discuss the issue. The customer complained that qc and patient results for crp were 1/10th of the expected crp concentrations. For an unknown reason, on 2016-07-21, the method was calibrated by using the prot2 cal calibrator (lot: 5mc001) with calibrator concentrations 1/10th of the than expected values. From that calibration all qc and patient samples run until 2016-09-20, a total of 2364 patient results, were reported with a falsely low concentrations of 1/10th the correct value. Once they have realized their error, the results have been corrected. Siemens completed an investigation of the incident and concluded it to be a user error. The bottle value for the calibrator was manually changed by the user from 2. 12 from to 0. 212 mg/dl, resulting in the lower than expected results. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[59046804]
Falsely depressed c-reactive protein (crp) results were obtained on qc and patient samples on the dimension vista 1500 instrument. A total of 2,364 patient results were reported to physicians during a period from 2016-07-21 through 2016-09-20 during which a user error during method calibration had impacted results. Patient results were questioned by physicians. The account repeated samples after the error was corrected. Corrected results were reported. There is no indication that patient treatment was altered or prescribed on the basis of the falsely depressed crp results. There was no report of adverse health consequences as a result of the falsely depressed crp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00406 |
| MDR Report Key | 6074653 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-02 |
| Date of Report | 2016-11-02 |
| Date of Event | 2016-07-21 |
| Date Mfgr Received | 2016-10-10 |
| Device Manufacturer Date | 2010-11-16 |
| Date Added to Maude | 2016-11-02 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Street | REGISTRATION NUMBER 1336181 101 SILVERMINE ROAD |
| 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 VISTA? |
| Generic Name | DIMENSION VISTA? 1500 SYSTEM |
| Product Code | DCN |
| Date Received | 2016-11-02 |
| Model Number | DIMENSION VISTA 1500 INTERNATIONAL |
| Catalog Number | 10444802 |
| Operator | SERVICE PERSONNEL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Address | REGISTRATION NUMBER 1336181 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? 1500 SYSTEM |
| Product Code | JJE |
| Date Received | 2016-11-02 |
| Model Number | DIMENSION VISTA 1500 INTERNATIONAL |
| Catalog Number | 10444802 |
| Operator | SERVICE PERSONNEL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| Manufacturer Address | REGISTRATION NUMBER 1336181 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-02 |