MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) to report that a discordant, falsely low beta human chorionic gonadotropin (bhcg) result was obtained on a patient sample on a dimension vista 500 instrument.Siemens reviewed instrument data.As per siemens instructions, the customer reviewed the integrity of the patient sample and retrieved an aliquot plate from waste a of the instrument to check the wells.The customer reported that multiple aliquot wells contained red cells.Siemens investigated the event and determined that the issue was consistent with sample integrity problem, which could affect assay signal.The cause of the discordant, falsely low bhcg result was due to a sample integrity issue.The instrument is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely low beta human chorionic gonadotropin (bhcg) result was obtained on a patient sample on a dimension vista 500 instrument.The initial result was reported to the physician(s), who questioned the result.On the next day, the sample was repeated on the same instrument, resulting higher.On (b)(6) 2018, the patient was redrawn and the new sample was run on an alternate instrument, resulting acceptably.The repeat result of 97 miu/ml was reported, as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low bhcg result.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8052880
• Report Number: 2517506-2018-00636
• Device Sequence Number: 19203712
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 11/08/2018

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 Model Number: DIMENSION VISTA 500
• Device Catalogue Number: 10488217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1