MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH CREATININE_2 (CREA_2)

Model Number ATELLICA CH CREATININE_2 (CREA_2)

Device Problem Low Test Results (2458)

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

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Contributing factors such as sample integrity and preanalytical variables cannot be ruled out as potential causes of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

Three discordant, falsely low creatinine_2 (crea_2) results were obtained on three patient samples on an atellica ch 930 analyzer using atellica ch creatinine_2 reagent.The discordant patient results were reported to the physician(s).The samples were repeated on the same system after changing the reagent pack, recovering higher.The higher results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant crea_2 results.

• Brand Name: ATELLICA CH CREATININE_2 (CREA_2)
• Type of Device: ATELLICA CH CREATININE_2 (CREA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 15287278
• MDR Text Key: 303354966
• Report Number: 2432235-2022-00242
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: 00630414596457
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K161494
• 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: 08/24/2022

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: Health Professional
• Device Model Number: ATELLICA CH CREATININE_2 (CREA_2)
• Device Catalogue Number: 11097596
• Device Lot Number: 221630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: No
• 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