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

Catalog Number	K6430 SMN 10445107
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant human chorionic gonadotropin (bhcg) result.Hsc has reviewed the information provided by the customer and the instrument data.Per the customer, the operator manually ordered a dilution on a sample that did not require dilution.Reprocessing of the sample undiluted, resulted as expected with no discrepancy.The cause of the event was due to a use error.Siemens has provided education to the customer.The customer agrees that this was not an issue with the system or product.No product or system nonconformance was identified in the siemens investigation of the event.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant human chorionic gonadotropin (bhcg) result was obtained on a patient sample on a dimension vista 1500 system.The discordant result was not reported to the physician(s).The same sample was reprocessed undiluted on the same day on an alternate dimension vista and a lower result was obtained.There are no reports of patient intervention or adverse health consequences due to the discordant bhcg result.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION VISTA® BETA 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: 8785846
• Report Number: 2517506-2019-00280
• Device Sequence Number: 16653620
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: 00842768015540
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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: 12/28/2019
• Device Catalogue Number: K6430 SMN 10445107
• Device Lot Number: 18362BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1