MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENTS

Catalog Number 10335891

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Information (3190)

Event Date 02/11/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENTS
• Type of Device: ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin, county antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 6367663
• MDR Text Key: 68605592
• Report Number: 2432235-2017-00153
• Device Sequence Number: 1
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10335891
• Device Lot Number: 374718
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1