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	10/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed patient sample result with microalbumin 2 (alb 2) obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
A discordant falsely depressed microalbumin 2 (alb 2) patient sample result was obtained on an atellica ®ch 930 analyzer.The falsely depressed patient result was reported to the physician(s), who questioned the result.The same sample was reprocessed on an alternate atellica ® ch 930 analyzer.The higher reprocessed result obtained 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 microalbumin 2 (alb 2) patient result.
Additional Manufacturer Narrative
Additional information (04-dec-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and instrument data files.Calibration was within the customer¿s acceptable ranges.The instrument data showed little to no change in reaction kinetics, and it indicated that there was no microalbumin present in the patient's sample.Hsc compared the level 1 calibrator and affected sample¿s reaction traces and noticed they are similar, indicating there was no albumin present in the patient's sample.Hsc observed no process errors on the system at the time of testing.No hardware/mechanical failures were observed.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2023-00312 was filed with the fda on 30-nov-2023.

• 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
• 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: 18236122
• Report Number: 2432235-2023-00312
• Device Sequence Number: 3176825
• Product Code: JIR
• UDI-Device Identifier: 00630414596310
• UDI-Public: 00630414596310
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 12/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Catalogue Number: SMN 11097610
• Device Lot Number: 231993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 69 YR
• Patient Sex: Female