MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-27 for DIMENSION VISTA? K6463 SMN10489099 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[58851168]
Analysis of the instrument and instrument data indicate that the cause for the discordant elevated e2 result is unknown. Siemens headquarters support center representatives have concluded that the pattern of repeatable elevated e2 results of approximately the same value obtained on multiple samples from the same patient with lower results on an alternate, non-siemens methodology is strongly suggestive of non-specific heterophilic antibody binding. No sample has been provided for siemens investigation. 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 instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[58851169]
A discrepant 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 level was obtained and a corrected report was issued. There is no indication that treatment was prescribed or altered on the basis of the discrepant elevated estradiol (e2) result. There was no report of adverse health consequences as a result of the discrepant elevated estradiol (e2) result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00344 |
| MDR Report Key | 6060523 |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-09-24 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2016-02-23 |
| Date Added to Maude | 2016-10-27 |
| 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 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 |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIMENSION VISTA? |
| Generic Name | DIMENSION VISTA? E2 ESTRADIOL FLEX? REAGENT CARTRIDGE |
| Product Code | NDR |
| Date Received | 2016-10-27 |
| Catalog Number | K6463 SMN10489099 |
| Lot Number | 16055AC |
| Device Expiration Date | 2017-01-19 |
| 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 NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-27 |