MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY; ADVIA CHEMISTRY CK_L CREATINE KINASE REAGENTS

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed creatine kinase (ck_l) result was obtained on a patient sample on an advia 2400 chemistry instrument.Siemens is evaluating the event.
Event or Problem Description
The customer reported that a falsely depressed creatine kinase (ck_l) result was obtained on a patient sample on an advia 2400 chemistry instrument.The initial result was not reported to the physician(s).The sample was auto repeated on the original instrument.The auto repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ck_l result.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00323 on 25-dec-2025.Additional information (29-jan-2026): siemens reviewed the instrument data and found that the analyzer flagged results with ¿u/u¿ absorbance limit errors, indicating that the reaction absorbance in certain test runs fell outside the allowable thresholds, which led to failure in reagent barcode label (rbl), calibration, quality control (qc), and patient results.The abnormal absorbance readings arose from a non-systemic interaction between the impacted ck_l reagent lot and specific analyzers/flexes.Although the reagent lot met specifications, variability in analyzer performance caused some units to interpret absorbance levels as out of range, producing inconsistent reaction absorbance behavior that triggered the u/u flags.The lot was within manufacturing specifications; however, instrument-specific performance variability led to u/u absorbance limit flags when used with this lot.This is categorized as a non-systemic analyzer¿reagent interaction, not a reagent malfunction, reflecting natural variability in reaction absorbance thresholds between analyzers, and lot-to-lot characteristics within specification but with slightly different optical behavior.Analyzer sensitivity differences caused some units to interpret absorbance at the limits as out of range.Siemens internal review confirmed the lot performed within specifications.Based on the siemens evaluation, it is determined that the abnormal reaction absorbance readings resulting from an analyzer-specific interaction with the impacted ck_l reagent lot potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.The investigation findings and investigation conclusions codes in the h6 sections were updated to reflect the additional information.

• Brand Name: ADVIA CHEMISTRY
• Common Device Name: ADVIA CHEMISTRY CK_L CREATINE KINASE REAGENTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road, crumlin; registration # 8020890; co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23891963
• Report Number: 2432235-2025-00323
• Device Sequence Number: 17277875
• Product Code: CGS
• UDI-Device Identifier: 00630414008943
• UDI-Public: (01)00630414008943(10)774608(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SMN 10729780
• Device Lot Number: 774608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male