MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE

Catalog Number	RF430 SMN 10444913
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2019-00091, 2517506-2019-00092, 2517506-2019-00093 were also filed for the same event.The customer contacted the siemens customer care center (ccc) and reported that a discordant, falsely elevated human chorionic gonadotropin (hcg) result was obtained on the dimension exl 200 system s/n (b)(4).Siemens headquarters support center (hsc) completed the investigation of the event.Hsc has reviewed the information provided and the instrument data.Hsc investigation indicates a patient specific interference causing a slightly elevated hcg result when compared to alternate methodologies.Per the instructions for use for the hcg assay on the dimension exl system: "patient samples may contain human heterophilic antibodies that could react with 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 from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." there is no evidence of a product nonconformance.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant elevated human chorionic gonadotropin (hcg) result was obtained on a patient sample on a dimension exl 200 instrument.The result was reported to the physician(s).The result was questioned at a later date when a new sample was reprocessed with two alternate methodologies and a lower result was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated hcg result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 8410019
• Report Number: 2517506-2019-00090
• Device Sequence Number: 16221367
• Product Code: DHA
• UDI-Device Identifier: 00842768013850
• UDI-Public: 00842768013850
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K970387
• 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): 03/11/2019

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: 09/20/2019
• Device Catalogue Number: RF430 SMN 10444913
• Device Lot Number: FC9263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR