MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® ALPHA-FETOPROTEIN FLEX® REAGENT CARTRIDGE

Catalog Number	K6454 SMN 10463378
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2019-00152 was filed for the same event.The customer contacted the siemens healthcare diagnostics customer care center (ccc) concerning discordant low alpha-fetoprotein (afp) patient results obtained on the dimension vista 1500 system.Siemens healthcare diagnostics headquarters support center (hsc) completed the investigation of the discordant, falsely depressed afp results.The customer stated that their quality control has been acceptable relative to peer means for afp and they stated that there was no reason to think there was an instrument issue.Hsc requested a sample to be returned to siemens for investigation but no sample was provided.Hsc has evaluated the instrument data logs and concluded that there was no reagent lot or assay issue.Hsc review of the afp instructions for use (ifu) shows that about 20% of hepatocellular cancer patients had values of greater than 1000 ng/ml.Hsc review of the ifu also shows that there is no hook effect up to 1,000,000 ng/ml.This sample was only tested up to 2,000 ng/ml.There has not been a challenge to the hook effect checked, so there is no determination as to if this is the cause of the discordant low result.The sample was not available to be returned to siemens and was not tested further to see if this issue is a hook effect issue.The cause of this event is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely depressed alpha-fetoprotein (afp) result was obtained on a patient's samples on the dimension vista 1500 system s/n (b)(4).The results were reported to the physician who questioned the results on the undiluted samples.The same sample was reprocessed on the same instrument with dilutions and higher results were obtained.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed afp results.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® ALPHA-FETOPROTEIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. bos 6101; newark DE 19714 6101
• MDR Report Key: 8506099
• Report Number: 2517506-2019-00151
• Device Sequence Number: 1628632
• Product Code: LOJ
• UDI-Device Identifier: 00842768019937
• UDI-Public: 00842768019937
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090236
• 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): 04/11/2019

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: 11/05/2019
• Device Catalogue Number: K6454 SMN 10463378
• Device Lot Number: 18309BE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1