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 2019-02-21 for DIMENSION VISTA? K4086 SMN 10445128 manufactured by Siemens Healthcare Diagnostics Inc..
[136892817]
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant vancomycin (vanc) results. Vanc assay calibration at the time the event was reported was within conformance. Vanc quality control (qc) samples successfully recovered within the customer established qc reference ranges before and after the observed flagged vanc results. Per the dimension vista operator's guide, the customer should not report results which prompt an abnormal assay flag. The customer should adhere to troubleshooting directions listed within the operator's guide which includes reprocessing the sample and processing quality control material to verify assay accuracy. After reporting of the issue to siemens healthcare diagnostics, the customer care center (ccc) discussed the appropriate action plan if a customer observes an abnormal assay result flag. Based on the evidence provided, hsc has attributed the reporting of the discordant vanc results to user error. There is no product non-conformance. The event was isolated to a singular patient. The dimension vista instrument operated as intended and the dimension vista instrument is fully operational. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[136892818]
Discordant vancomycin (vanc) results were obtained on a patient sample on the dimension vista 500 system. An abnormal assay flagged result was reported to the physician(s). The same sample was repeated on an alternate vista instrument and abnormal assay flagged results were also obtained. There are no reports of patient intervention or adverse health consequences due to the discordant vanc results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2019-00081 |
| MDR Report Key | 8358257 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-01-27 |
| Date Mfgr Received | 2019-01-27 |
| Device Manufacturer Date | 2018-09-25 |
| Date Added to Maude | 2019-02-21 |
| 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 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? VANC VANCOMYCIN FLEX? REAGENT CARTRIDGE |
| Product Code | LEH |
| Date Received | 2019-02-21 |
| Catalog Number | K4086 SMN 10445128 |
| Lot Number | 18269BA |
| Device Expiration Date | 2019-09-26 |
| 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 | 2019-02-21 |