MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)

Catalog Number SMN 11097533

Device Problem Low Test Results (2458)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

A discordant falsely depressed enzymatic creatinine_2 (ecre_2) patient sample result was obtained on an atellica ® ch 930 analyzer.The falsely depressed patient result was reported to the physician and was questioned.The same sample was reprocessed on the same atellica ® ch 930 analyzer.The higher reprocessed result obtained was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed enzymatic creatinine_2 (ecre_2) patient result.

Manufacturer Narrative

An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed enzymatic creatinine_2 (ecre_2) patient result obtained on an atellica ® ch 930 analyzer.Siemens is investigating the event.

Manufacturer Narrative

Additional information (15-feb-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed preventative maintenance that was part of standard troubleshooting including service method testing relevant to issues of this nature.Quality control recovered within the customer's expected ranges.Hsc reviewed photometric data comparison which showed little to no reaction occurred for the discordant result indicating there was little to no creatinine in the reaction cuvette and the dilution aspiration pressure profile analysis shows the discordant result had an abnormal profile indicating a partial aspiration of the primary sample occurred.Hsc concluded that the cause of the event was consistent with not enough primary sample being aspirated to create the predilution.The customer is operational.The device is performing within specifications.No further evaluation is required.Sections h3 and h6 have been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00032 was filed on 08-feb-2024.

• Brand Name: ATELLICA CH
• Type of Device: ATELLICA CH ENZYMATIC CREATININE_2 (ECRE_2)
• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18669272
• MDR Text Key: 335947501
• Report Number: 2432235-2024-00032
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K070727
• 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,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Catalogue Number: SMN 11097533
• Device Lot Number: 130165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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: 80 YR
• Patient Sex: Female