Catalog Number 10335891 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
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Patient Problem
No Information (3190)
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Event Date 02/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens healthcare support center (hsc) has reviewed the information and has concluded that there is no siemens method or reagent issue.This was due to an user error.The customer is modifying the ready to use siemens reagent, which is not in accordance with the manufacturer's instructions for use (ifu).The reagent modification that the customer is performing by doubling the amount of reagent by diluting with water is not validated and is not supported by siemens.The cause of the discrepant results is unknown.No further investigation of the device is required.
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Event Description
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The customer of an advia chemistry 2400 glucose hexokinase_3 (gluh_3) reagent contacted a siemens customer care center (ccc) specialist to report discordant results.The customer has been diluting the gluh_3 reagents with water in a 1:1 ratio and using the diluted reagents to run patient samples.The customer has also extended the calibration ranges on the system to allow for a successful calibration.The customer obtained discordant patient results upon repeating some of the patient samples.The original results and repeat results were obtained on diluted reagents.Initial patient results with the diluted reagents have been reported to the physician(s).It is unknown if the repeat results with the diluted reagents have been reported to the physician(s).It is unknown if any medical procedure or treatment was administered to patients due to the discrepant glucose hexokinase results.It is unknown if there was any delay in administering medical procedures or treatments to patients due to the discrepant glucose hexokinase results.
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Manufacturer Narrative
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The initial mdr 2432235-2017-00153 was filed on march 1st, 2017.Additional information (03/09/2017): the customer provided additional information on the glucose hexokinase_3 (gluh_3) reagent lot that was used and sid numbers for the gluh_3 data.
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Search Alerts/Recalls
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