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
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ADVIA CHEMISTRY XPT - ECRE_2
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9802039
• Report Number: 2432235-2020-00227
• Device Sequence Number: 779125
• Product Code: JFY
• UDI-Device Identifier: 00630414526690
• UDI-Public: 00630414526690
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K070727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1