MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH 930 CREATININE_2 (CREA_2); ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

The customer obtained a falsely depressed creatinine_2 (crea_2) result on a patient sample on an atellica ch 930 analyzer, serial number (s/n): (b)(6).The initial result was reported to the physician, who questioned the result.The sample was retested, and a higher result was obtained.The retest result was reported as the correct result to the physician.There are no known reports of patient intervention or adverse health consequences due to falsely depressed crea_2 result.

Manufacturer Narrative

An outside of the united states (ous) customer contacted siemens customer care center to report an observation of a falsely depressed atellica ch 930 creatinine_2 (crea_2) result.Siemens investigated the issue.The instrument data and complaint documentation were reviewed, and the following was noted: results data shows the crea_2 method was calibrated on (b)(6)2023 utilizing reagent pack/well 1, 12130, 22180210032223100102497, 1, 12130, 2218022003222310.The calibration was acceptable, and quality control (qc) run on this reagent pack/well and an alternate one (0, 12143, 22180210032223100102493, 0, 12143, 2218022003222310) that was on board at the time was within acceptable limits indicating the method was working as intended.Patient result was generated from reagent pack/well 0, 12130, 22180210032223100102497, 0, 12130, 2218022003222310.Qc was not run on this well prior to patient testing.Qc was run later in the day at approximately 1755 local time after the discordant results were generated and the qc was low and out of acceptable limits.The alternate reagent well that was opened and onboard was qc'ed at the same time and generated acceptable results.This indicates that the issue was isolated to the one well set.Process error logs show there were 7343 errors associated with the reagent loader arm and reagent manual load station between (b)(6)2023.The last error occurred at approximately 0956 local time prior to the discordant result being generated.Reagent event data shows reagent pack/well 0, 12130, 22180210032223100102497, 0, 12130, 2218022003222310 was opened during the time the reagent loader was having issues on 6/6/2023.Level sense data and aspiration pressure profiles were reviewed and there were no abnormalities.The data from theses queries and analysis indicates the reagent arms, sample arm, and dilution arm were functioning as intended without error and there were no issues with aspirating/dispensing reagent or sample.Based on review of all the data, siemens has determined the probable cause was due to a potentially contaminated reagent well.Qc performed on subsequent wells shows the issue was isolated to the one well set.A product performance issue has not been identified.The customer is operational.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.".

• Brand Name: ATELLICA CH 930 CREATININE_2 (CREA_2)
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; registration # 8020890; crumlin co. antrim BT29 4Q; UK BT29 4Q
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17287244
• MDR Text Key: 319401871
• Report Number: 1219913-2023-00130
• 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: 07/09/2023

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 Expiration Date: 10/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 221802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/10/2023
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male