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.
[67383167]
The account contacted the siemens customer care center (ccc). Based upon the information provided the cause of the discordant low ca results is the acceptance of a calibration with qc out of range. Instrument log data shows l2 signal results indicate poor chemistry 1 calibrator preparation. The customer care center instructed the customer to follow the chemistry 1 calibrator instructions for use (ifu) reagent preparation instructions: "allow chem 1 calibrator to thaw and equilibrate to room temperature (22 - 28 c) for one hour. Before use, gently invert the calibrator vials at least 10 times to ensure the contents are thoroughly mixed. Do not vortex. " the issue was resolved when the customer recalibrated calcium with fresh thawed and mixed calibrator following ifu instructions. Calibration and qc now passed. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[67383168]
Discordant low calcium (ca) results were obtained on qc and patient samples on the dimension vista 500 system immediately after calibration of a new calcium reagent lot. Patient results were reported. The same samples were rerun on the same instrument after recalibration with newly prepared chemistry i calibrators and higher results were obtained. One of the patient samples was repeated on an alternate instrument. Corrected results were reported. There are no known reports of patient intervention or adverse health consequences due to the discordant low ca results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00116 |
| MDR Report Key | 6327504 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-01-19 |
| Date Mfgr Received | 2017-01-20 |
| 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 |