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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® SYSTEM CA 19-9 FLEX® REAGENT CARTRIDGE Back to Search Results
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.
 
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Brand NameDIMENSION VISTA® SYSTEM
Type of DeviceCA 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 Key5630092
MDR Text Key44347203
Report Number2517506-2016-00232
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K100375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/18/2016
Device Catalogue NumberK6457 SMN10464358
Device Lot Number15139AC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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