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 2017-02-28 for DIMENSION VISTA? K6463 SMN10489099 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[68597226]
Analysis of the instrument and instrument data indicate that the cause for the discordant elevated e2 result is unknown. A siemens headquarters support center representative evaluated the information provided. There was no indication an instrument issue since the result replicated across different dimension vistas at the site. No heterophilic antibody testing was conducted by the customer or siemens. No sample was provided for siemens evaluation. While it was commented that the patient was not on medications, the following statement from the ifu cautions customers: "with the advent of new steroid based medications (analogues) with similar chemical structures to estradiol, there is the possibility of cross-reactivity and results inconsistent with the patients clinical history. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. " the instructions for use for the e2 flex? Reagent cartridge contains the following information: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference cannot be guaranteed. A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. " the device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[68597227]
A discordant elevated estradiol (e2) result was obtained on a patient sample on the dimension vista system. The result was reported to a physician who questioned the result. The sample was tested with a different, non-siemens methodology. A lower result was obtained and a corrected report was issued. There are no known reports of patient intervention or adverse health consequences due to the discordant elevated e2 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00140 |
| MDR Report Key | 6367199 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-28 |
| Date of Report | 2017-02-28 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-10-03 |
| Date Added to Maude | 2017-02-28 |
| 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 | MEDICAL TECHNOLOGIST |
| 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? E2 ESTRADIOL FLEX? REAGENT CARTRIDGE |
| Product Code | NDR |
| Date Received | 2017-02-28 |
| Catalog Number | K6463 SMN10489099 |
| Lot Number | 16277BB |
| Device Expiration Date | 2017-08-29 |
| 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 | 2017-02-28 |