MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY ENZYMATIC CREATININE_2 REAGENTS

Model Number ADVIA CHEMISTRY ENZYMATIC CREATININE_2 REAGENTS

Device Problem Insufficient Information (3190)

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

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer.The customer has informed hsc that this may be a sample specific issue, and that here have been no other discordants for the creatinine_2 assay on the advia chemistry system.The cause of the falsely elevated patient samples is unknown.

Event Description

The customer has obtained a falsely high result for the creatinine_2 assay on one patient sample on an advia chemistry 2400 instrument.The sample was run initially on (b)(6) 2016.A new sample draw was then run on an alternate platform and the result was lower.Another new sample draw was repeated on the same advia chemistry instrument on (b)(6) 2016 and the result was still higher than expected.The customer then decided to dilute the patient sample at 3 different dilution and the result was lower.The initial result was reported to the physician(s) and questioned.The result obtained on the alternate platform was also reported to the physician(s).There were no reports of patient intervention or adverse health consequences due to the high result on the patient sample for creatinine.

Manufacturer Narrative

Corrected information (10/26/2016): the reagent lot number for ecrea_2 and the udi number was listed incorrectly.This report has corrected information.In addition siemens headquarters support center (hsc) received feedback from a siemens customer service engineer (cse) at the site, regarding the ecrea_2 assay, whereas the use of the crea_2 jaffe assay may be more representative for the patient sample being tested.Siemens hsc has recommended based on this information provided by the cse that the customer use the crea_2 jaffe method, as there appears to be something in the patient sample interfering with the ecrea_2 result.The cause of the falsely elevated result on the patient sample is a possible interferant.

Manufacturer Narrative

The initial mdr 2432235-2016-00624 was filed on 10/18/2016.A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer.The customer has informed hsc that this may be a sample specific issue, and that here have been no other discordants for the enzymatic creatinine_2 assay on the advia chemistry system.Additional information (10/20/2016): upon further review of the complaint it was noted by a siemens designated complaint handling (dcu) representative that the correct assay was enzymatic creatinine_2 and not creatinine_2.Based on this information, the following sections were updated to reflect the correction.

Event Description

The customer has obtained a falsely high result for the enzymatic creatinine_2 ( ecrea_2) assay on one patient sample on an advia chemistry 2400 instrument.The sample was run initially on (b)(6) 2016.A new sample draw was then run on an alternate platform and the result was lower.Another new sample draw was repeated on the same advia chemistry instrument on (b)(6) 2016 and the result was still higher than expected.The customer then decided to dilute the patient sample at 3 different dilution and the result was lower.The initial result was reported to the physician(s) and questioned.The result obtained on the alternate platform was also reported to the physician(s).There were no reports of patient intervention or adverse health consequences due to the high result on the patient sample for enzymatic creatinine_2.

• Brand Name: ADVIA CHEMISTRY ENZYMATIC CREATININE_2 REAGENTS
• Type of Device: ADVIA CHEMISTRY ENZYMATIC CREATININE_2 REAGENTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SEKISUI DIAGNOSTICS PEI INC. (REG#8020316); 70 watts avenue; crumlin; charlottetown, pe c1e 2b9, BT29 4QY; CA BT29 4QY
• Manufacturer Contact: aarti aziz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242683
• MDR Report Key: 6036111
• MDR Text Key: 57686112
• Report Number: 2432235-2016-00624
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070727
• 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,Followup
• Report Date: 10/26/2016

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
• Device Operator: No Information
• Device Model Number: ADVIA CHEMISTRY ENZYMATIC CREATININE_2 REAGENTS
• Device Catalogue Number: 10309050
• Device Lot Number: 48352
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/20/2016; 10/26/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1