MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® SYSTEM; CA 19-9 FLEX® REAGENT CARTRIDGE

Catalog Number K6457 SMN10464358

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the falsely depressed ca 19-9 results is unknown.The complaint involved one individual patient's samples drawn over the course of two days.The internal investigation conducted by the account showed lower results with lot 15139ac on two separate dimension vista instruments than results with the same samples on the same two instruments with two alternate flex lots.Qc remained within laboratory ranges for all three lots on both instruments.The incident is suggestive of a sample specific issue peculiar to the one individual patient.The patient results were not reported from the dimension vista systems and the specimens were sent to an outside laboratory for testing.The account suspended ca 19-9 testing from the vista instruments.The ca 19-9 flex(r) reagent cartridge ifu cautions: "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 samples have been provided to siemens for headquarters service center evaluation.No further evaluation of the device is required.

Event Description

Falsely depressed ca 19-9 results were obtained on an individual patient's samples on the dimension vista system.The results were not reported to the physician.The samples were repeated with alternate lots of the ca 19-9 flex reagent cartridges and higher results were obtained.Patient treatment was not altered on the basis of the falsely depressed ca 19-9 results.There was no report of adverse health consequences as a result of the falsely depressed ca 19-9 results.

Manufacturer Narrative

The initial mdr 2517506-2016-00232 was filed on may 4, 2016.The customer returned the sample to siemens healthcare diagnostics for evaluation.The siemens technical service laboratory tested the returned sample and has verified the high discordant results were determined to be consistent with non-specific antibody binding.The ca 19-9 flex(r) reagent cartridge ifu cautions: "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." the root cause of the discrepancy is heterophilic interference of the sample with the dimension vista ca 19-9 method.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA® SYSTEM
• Type of Device: CA 19-9 FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5630092
• MDR Text Key: 44347203
• Report Number: 2517506-2016-00232
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2016
• Device Catalogue Number: K6457 SMN10464358
• Device Lot Number: 15139AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1