MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER

Model Number ATELLICA CH 930 ANALYZER

Device Problem Low Test Results (2458)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

The customer reported that falsely depressed creatinine_2 (crea_2) and albumin (alb) results were obtained on 1 patient sample on an atellica ch 930 analyzer.The erroneous results were reported to the physician(s).The sample was repeated on an alternate atellica ch 930 analyzer.The repeat results were higher than the erroneous results.The repeat results were reported, as the correct results, to the physician(s) and were in line with the patient¿s details.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed crea_2 and alb results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center to report that falsely depressed creatinine_2 (crea_2) and albumin (alb) results were obtained on 1 patient sample on an atellica ch 930 analyzer.Quality controls (qcs) and calibration were acceptable on the day of the event.Since the erroneous results, the quality controls were repeated, and resulted within acceptable ranges.Instrument data was not available for further analysis of this event.This was an isolated event related to one patient sample.The cause of the falsely depressed crea_2 and alb results is unknown.The analyzer is performing within specifications.No further evaluation of this analyzer is required.

• Brand Name: ATELLICA CH 930 ANALYZER
• Type of Device: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 18944691
• MDR Text Key: 339134481
• Report Number: 2432235-2024-00057
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: 00630414002163
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151767
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATELLICA CH 930 ANALYZER
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female