MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ENZYMATIC CREATININE_3 (ECRE3); ENZYMATIC METHOD, CREATININE

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

The customer obtained discordant enzymatic creatinine_3 (ecre3) for a patient serum sample processed on the atellica ch 930 analyzer, serial number (s/n) (b)(6) and reagent lot 123531.The discordant result was not reported to the physician.The discordant result was discovered when the customer performed post-analysis/review of results from patient samples with initial low ecre3 results.The customer retested the samples on a different analyzer and sample id 1739795101 was found to be discordant.There are no allegations of patient or user intervention or adverse health consequences due to the discordant ecre3 result.

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens customer care center to report an observation of a falsely depressed atellica ch enzymatic creatinine3 (ecre3) patient result.Quality control (qc) recovered within acceptable ranges for all control levels.The calibration used in sample processing was acceptable.The interpretation of results section of the instructions for use (ifu) states, "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." the limitations section of the ifu states, "as with any chemical reaction, you must be alert to the possible effect of unknown interferences from medications or endogenous substances.The laboratory and physician must evaluate all patient results in light of the total clinical status of the patient." siemens is investigating.

• Brand Name: ENZYMATIC CREATININE_3 (ECRE3)
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18181522
• MDR Text Key: 328632576
• Report Number: 1219913-2023-00295
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 00630414610948
• UDI-Public: 00630414610948
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K212223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2024
• Device Model Number: N/A
• Device Catalogue Number: 11537216
• Device Lot Number: 123531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Date Device Manufactured: 12/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female