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

Catalog Number	RF430 SMN10444913
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc) and reported a discordant, falsely elevated human chorionic gonadotropin (hcg) patient result on the dimension exl system.The cause of the discordant elevated hcg result was due to operator error.The initial result was accompanied with a "high absorbance (hi a) error" flag.The same sample was repeated with the operator indicating a 1:5 dilution on the instrument however, the operator did not manually dilute the sample which resulted in an incorrect high result.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 the dimension exl system.The result was reported to the physician who questioned the result.The same sample was reprocessed at an alternate facility on an alternate siemens system and a lower result was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant hcg result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® HCG HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8162387
• Report Number: 2517506-2018-00693
• Device Sequence Number: 14045944
• Product Code: DHA
• UDI-Device Identifier: 00842768013850
• UDI-Public: 00842768013850
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/13/2018

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: 05/16/2019
• Device Catalogue Number: RF430 SMN10444913
• Device Lot Number: FA9136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR