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 2017-02-13 for DIMENSION VISTA? KC110B manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[67261526]
The cause of the discordant low ca results is user error during calibration of a new lot of calcium reagent. Siemens headquarters support center personnel evaluated the instrument log data and concluded that the data was consistent with the chemistry 1 calibrator levels having been incorrectly switched during calibration. The customer later stated that they had manually printed calibrator barcodes and that the barcodes were incorrectly placed on the calibrator vials. The issue was resolved when the customer recalibrated calcium with properly labeled calibrators. Qc now passed and corrected patient results were reported. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[67261527]
Discordant high calcium (ca) results were obtained on qc and patient samples on the dimension vista 1500 system immediately after calibrating a new reagent lot. Patient results were reported. The same samples were rerun on the same instrument after recalibration and lower results were obtained for nine samples. Corrected patient results were reported. There are no known reports of patient intervention or adverse health consequences due to the discordant high ca results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00103 |
| MDR Report Key | 6325996 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-01-18 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2017-02-13 |
| 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 | GLASGOW BUSINESS COMMUNITY 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 - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 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? CHEMISTRY 1 CALIBRATOR |
| Product Code | JIX |
| Date Received | 2017-02-13 |
| Catalog Number | KC110B |
| Lot Number | 6DM081 |
| Device Expiration Date | 2017-04-15 |
| 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 - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |