MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH IRON_2 (IRON_2)

Model Number	N/A
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) and noted that quality control (qc) recovered within range.Siemens is investigating the event.
Event or Problem Description
The customer obtained a discordant, falsely depressed, microalbumin_2 (alb_2) result on a patient sample when performing repeat testing on an atellica ch 930 analyzer.The customer did not report the repeat result and noted that the initial result was correct and reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the falsely depressed microalbumin_2 (alb_2) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2022-00052 on 23-feb-2022.Correction (july 2022): sections b5 and b6 of the initial mdr incorrectly referenced a "falsely depressed microalbumin 2 (alb 2) result." sections b5 and b6 are updated with the correct reference "falsely elevated microalbumin 2 (alb 2) result." siemens reviewed additional information regarding the falsely elevated microalbumin 2 (alb 2) result and concluded no hardware-related malfunction with the atellica ch 930 analyzer.Siemens healthcare diagnostics further investigated the issue and confirmed the potential for falsely elevated results observed due to reagent carryover from atellica ch 930 iron 2 (iron 2) into atellica ch microalbumin 2 (alb 2).This issue impacts urine patient samples, quality control samples, and calibrators for the alb 2 assay.Starting 2022-06-28 an urgent medical device correction (umdc, letter achc22-06.A.Us) was sent to us customers, and an urgent field safety notice (ufsn, letter achc22-06.A.Ous) was sent to ous customers.The umdc and ufsn explain the potential for carryover for iron 2 into alb 2 on the atellica ch 930 and provides instructions to the customers.
Event or Problem Description
The customer obtained a discordant, falsely elevated, microalbumin 2 (alb 2) result on a patient sample during initial testing performed on an atellica ch 930 analyzer.The result was not reported to the physician(s).The customer used the same sample and analyzer to perform repeat testing and obtained a lower result.The result was considered to be correct and reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the falsely elevated microalbumin 2 (alb 2) result.

• Brand Name: ATELLICA CH IRON_2 (IRON_2)
• Common Device Name: ATELLICA CH IRON_2 (IRON_2)
• 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 NJ BT29 4QY; UK BT29 4QY
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 13587312
• Report Number: 2432235-2022-00052
• Device Sequence Number: 4673801
• Product Code: JIY
• UDI-Device Identifier: 00630414596402
• UDI-Public: 00630414596402
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K991576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022
• 2 Devices were Involved in the Event: 1 2

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: 11097601
• Device Lot Number: ALL LOTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 07/08/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-07/01/2022-004-C
• Patient Sequence Number: 1
• Patient Sex: Unknown