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

Catalog Number	K6430 SMN 10445107
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00274 was filed for the same event.The customer contacted siemens customer care center (ccc) and reported a discordant, falsely elevated human chorionic gonadotropin (hcg) result obtained on the dimension vista instrument.Siemens headquarters support center (hsc) has reviewed the instrument data and completed their evaluation.There were no instrument issues or malfunctions.Qc was within range during testing.There is no evidence of a system or reagent malfunction based on the information provided.The customer states the patient is not pregnant.No further information can be provided by customer on this issue.The customer stated that the first two samples were drawn offsite and submitted by the patient.(the patient is a phlebotomist that is employed by customer).Both the lab operations manager and lab medical director from the customer site stated that tampering with the sample could have been a potential cause of this event.Specimen integrity was questioned by the hospital and repeat samples recovered as expected.The initial sample was drawn in an uncontrolled environment and questioned by the lab.Based on the data and system performance around the time of the elevated results, suspect sample integrity to be the root cause of this event.No product non-conformance was identified.No further evaluation of the device is required.
Event or Problem Description
A discordant falsely elevated beta human chorionic gonadotropin (bhcg) result was obtained on a patient sample on the dimension vista instrument.The sample was repeated on an alternate vista instrument to confirm the initial high result.The result was reported to the health care practitioner (s) who questioned the result.There was no known impact on patient treatment or care and no alleged patient harm due to the discordant elevated bhcg result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® BHCG BETA 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: 7472359
• Report Number: 2517506-2018-00273
• Device Sequence Number: 13882382
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: 00842768015540
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 11/30/2018
• Device Catalogue Number: K6430 SMN 10445107
• Device Lot Number: 17334BC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/30/2018
• 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