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 2017-03-13 for DIMENSION VISTA? K6463 SMN10489099 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[69797776]
Analysis of the instrument and instrument data indicate that the cause for the possible discordant elevated estradiol (e2) result is unknown. According to the customer, the physician stated a scan of the patient was normal and there were no clinical symptoms but he thought that a small tumor wouldn't be visible on the image and then decided to operate on the patient because of the very high result of e2. When the last sample done after the operation was still high, he questioned the result. The intended use for the loci estradiol flex reagent cartridge states: "the e2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the dimension vista? System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy. " the clinician appears to have utilized the product for an off-label, non-indicated use. No sample was provided for siemens evaluation. Heterophilic antibody testing was conducted by the customer. Use of a heterophile blocking tube (hbt) resulted in an approximate decrease of 63% from the sample left untreated prior to analysis. The hbt reagent consists of specific binders intended to inactivate heterophilic antibodies. Based on the significant difference between e2 results it is suspected that the hbt binders were indeed able to bind to heterophilic antibodies present in the specimen thus causing a dramatic decrease in their ability to interfere with the vista e2 method. The results indicate that this is not a method or instrument issue. 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. " all dimension vista results for estradiol for this patient were substantially elevated above expected ranges. Estradiol results elevated to this magnitude when truly normal would likely appear discordant when interpreted in the context of clinical history and presentation/symptomology. Symptoms of elevated estrogen levels include weight gain, changes in the menstrual cycle, bloating, headaches, mood swings, etc. There are no clinical guidelines we are aware of whereby an oophorectomy would be warranted based solely on elevated estradiol results. It is our understanding that, during investigations for estrogen-secreting tumors, other markers of germ cell and sex cord stromal tumors of the ovary would be measured, including afp, hcg, ldh, inhibin, testosterone, dhea, and amh and that these results would be correlated with imaging studies of the adrenal glands and/or ovaries prior to surgical intervention. Statements attributed to the physician and patient are derived from information submitted to the complaint handling system and haven't been verified. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[69797777]
A possible discordant elevated estradiol (e2) result was obtained on a patient sample on (b)(6) 2016 on the dimension vista 500 international system. The possible discordant e2 result was reported to a physician and was not questioned initially. The same patient was redrawn on later dates and similarly possible elevated results were obtained. Those samples have been retested on the dimension vista with the same results and reported to the physician, these results were not questioned by the physician. The customer stated that the patient's scan was normal and the patient had an oophorectomy (ovariectomy) subsequent to the scan. The customer stated that the physician thought that a small tumor wouldn't be visible in the image and there were no clinical symptoms but decided to operate on the patient due to the possible discordant elevated e2 result in (b)(6) 2016 after the (b)(6) 2016 possible discordant elevated e2 result was reported. The customer stated that on (b)(6) 2017 the patient came back to the lab to complain about the e2 results from the sample from (b)(6) 2016. Subsequent samples tested after the oophorectomy were similarly possibly elevated. The (b)(6) 2016 sample was retested on (b)(6) 2017 on an alternate siemens instrument system with a different methodology and a lower result was obtained. There is no further indication of adverse health consequences due to the possible discordant elevated e2 result. Statements attributed to the physician and patient are derived from information submitted to the complaint handling system and haven't been verified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00193 |
| MDR Report Key | 6399556 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-13 |
| Date of Report | 2017-03-13 |
| Date of Event | 2016-06-14 |
| Date Mfgr Received | 2017-02-16 |
| Device Manufacturer Date | 2015-11-11 |
| Date Added to Maude | 2017-03-13 |
| 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? E2 ESTRADIOL FLEX? REAGENT CARTRIDGE |
| Product Code | NDR |
| Date Received | 2017-03-13 |
| Catalog Number | K6463 SMN10489099 |
| Lot Number | 15314BC |
| Device Expiration Date | 2016-10-05 |
| 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 | 1. Other | 2017-03-13 |