MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ECRE_2 REAGENTS (4 X 350 TESTS) - ENZ; ADVIA CHEMISTRY XPT - ECRE_2

Model Number ADVIA CHEMISTRY XPT - ECRE_2

Device Problem Low Test Results (2458)

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

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center.Siemens headquarters support center (hsc) reviewed the information provided by the customer.Hsc found that after recalibration of a new reagent pair, ecre_2 reagent lot 54373, the quality control (qc) was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.A repeat of the same sample yielded expected results.Hsc could not determine the cause of the discrepant result.Contributing factors such as reagent contamination at the customer site cannot be ruled out.Hsc did not identify a potential product issue.The cause for the discordant falsely elevated ecre_2 sample result is unknown.The instrument is performing within specification.No further evaluation of the device is required.

Event Description

One discordant, falsely depressed enzymatic creatinine_2 (ecre_2) result was obtained on a single patient using advia chemistry xpt analyzer.The initial result was reported to the physician(s).The repeat result using an alternate advia chemistry xpt analyzer was considered correct and was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ecre_2 results.

• Brand Name: ECRE_2 REAGENTS (4 X 350 TESTS) - ENZ
• Type of Device: ADVIA CHEMISTRY XPT - ECRE_2
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• Manufacturer (Section G): SEKISUI DIAGNOSTICS PEI INC.; 70 watts avenue; registration # 8020316; charlottetown, pe C1E 2 B9; CA C1E 2B9
• Manufacturer Contact: mardochee timolien ; 511 benedict avenue; tarrytown, ny ; 5242503
• MDR Report Key: 9802039
• MDR Text Key: 193081709
• Report Number: 2432235-2020-00227
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 00630414526690
• UDI-Public: 00630414526690
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: ADVIA CHEMISTRY XPT - ECRE_2
• Device Catalogue Number: 10335869
• Device Lot Number: 54373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• 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