MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® LOCI CA 19-9

Catalog Number	K6457 SMN10464358
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2019-00399, 2517506-2019-00400, 2517506-2019-00401 and 2517506-2019-00402 were filed for the same event.The customer contacted the siemens healthcare diagnostics customer care center (ccc) and reported that discordant, falsely elevated cancer antigen 19-9 (ca 19-9) patient results were obtained on a dimension vista 500 instrument.Siemens is investigating the event.
Event or Problem Description
Discordant, falsely elevated cancer antigen 19-9 (ca 19-9) results were obtained on a patient serum/plasma sample on a dimension vista 500 instrument.Siemens technical applications specialist (tas) processed an undiluted sample from the patient and obtained an elevated result which was considered discordant.The same sample was reprocessed with dilutions and lowers results were obtained.The tas performed a new calibration with a new calibrator and the sample showed an elevated result when processed undiluted and lower results when diluted.After treatment for heterophile antibodies, the sample gave a lower result.Due to elevated ca 19-9 results, a cat scan (ct) with contrast was performed on the patient.There were no adverse health consequences due to the discordant falsely elevated ca 19-9 results or due to the cat scan performed on the patient.
Additional Manufacturer Narrative
Mdr 2517506-2019-00404 was filed on 16-oct-2019.Additional information (20-nov-2019): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely elevated cancer antigen 19-9 (ca 19-9) results.Hsc received an update from the customer that heterophilic blocking tubes (hbt) were used to show that the discordant results with this patient were due to heterophilic antibodies.Per the dimension vista instructions for use (ifu) for ca 19-9: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution." no patient sample was provided to siemens for internal testing.This patient specific event is not a potential product issue.The customer continues to use the analyzer to report results.The device is performing within specifications.No further evaluation is required.Mdrs 2517506-2019-00399_s1, 2517506-2019-00400_s1, 2517506-2019-00401_s1 and 2517506-2019-00402_s1 were filed for the same event.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® LOCI CA 19-9
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 9198356
• Report Number: 2517506-2019-00404
• Device Sequence Number: 14239613
• Product Code: NIG
• UDI-Device Identifier: 00842768028533
• UDI-Public: 00842768028533
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100375
• 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,Followup
• Report Date (Section B): 12/13/2019

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: 02/22/2020
• Device Catalogue Number: K6457 SMN10464358
• Device Lot Number: 19053BB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR