MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH MICROALBUMIN_2 (¿ALB_2)

Catalog Number	SMN 11097610
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained erroneously depressed microalbumin_2 (alb_2) results on two (2) patient samples on an atellica ch 930 analyzer.The erroneous results were reported to the physician and were not questioned.The same samples were reprocessed on an alternate atellica ch 930 analyzer.The higher reprocessed results obtained were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed microalbumin_2 (alb_2) results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed microalbumin_2 (alb_2) results obtained on two (2) patient samples on an atellica ch 930 analyzer.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the available instrument data files and the information provided by the customer.Quality control (qc) results were flagged with no calculation error.Hsc reviewed the calibration data and found that the signal recovery of the calibration in use was inconsistent with the surrounding calibration attempts.The customer used a fresh calibrator material yielded an acceptable method calibration.Hsc concluded that the cause of the event was consistent with the poor calibration curve.Hsc could not determine whether the curve shape failure was related to a compromised calibrator material or operator error.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH MICROALBUMIN_2 (¿ALB_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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21025015
• Report Number: 2432235-2024-00361
• Device Sequence Number: 18418771
• Product Code: JIR
• UDI-Device Identifier: 00630414596310
• UDI-Public: (01)00630414596310(10)242365(17)250901
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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 Expiration Date: 09/01/2025
• Device Catalogue Number: SMN 11097610
• Device Lot Number: 242365
• 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: 12/04/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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: Unknown