MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® E2 ESTRADIOL FLEX® REAGENT CARTRIDGE

Catalog Number	K6463
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the customer care center concerning discordant elevated estradiol result.Siemens headquarters support center (hsc) evaluated the information provided and concluded their investigation of the event.No instrument, qc, other patient result, or assay related issues were reported.No e2 assay or vista system issues have been identified.The cause of the discordant elevated estradiol result is unknown.Results were questioned by the provider as higher results than were expected.It is unclear when the sample was drawn in relationship to the removal of the ovaries.Here the estradiol result was believed to be erroneously elevated compared to two other methods.The patient was on oral contraceptive medication, loette, which contains estradiol.The ifu indicates under the limitations of procedure section: "with the advent of 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".The device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant elevated estradiol (e2) result was obtained on a patient's sample on the dimension vista 1500 system.The same sample was tested by two alternate non-siemens methodologies and lower results were obtained consistent with physician expectations.There are no reports of treatment change or adverse health consequences due to the discordant elevated e2 result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® E2 ESTRADIOL FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7787093
• Report Number: 2517506-2018-00459
• Device Sequence Number: 19387655
• Product Code: NDR
• UDI-Device Identifier: 00842768026461
• UDI-Public: 00842768026461
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2019
• Device Catalogue Number: K6463
• Device Lot Number: 18039BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR