MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH LACTATE_2 (LAC_2)

Model Number	ATELLICA CH LACTATE_2 (LAC_2)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc) to report that a falsely depressed lactate_2 (lac_2) patient sample test result was obtained on an atellica ch 930 analyzer.Siemens evaluated the available information and found that the instructions for use (ifu) for the lactate reagent specifies a reagent 1 (r1) preparation step prior to loading the reagent onto the analyzer.The reagent preparation step was not performed by the operator.There were no issues with other assays.The cause of the event was improper r1 reagent preparation by the operator.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A falsely depressed lactate_2 (lac_2) patient sample test result was obtained on an atellica ch 930 analyzer using the atellica ch lactate_2 (lac_2) reagent.The initial test result was reported to the physician(s), who questioned the result.The same sample was repeated on an alternate atellica ch 930 analyzer.The repeat result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ATELLICA CH LACTATE_2 (LAC_2)
• Common Device Name: ATELLICA CH LACTATE_2 (LAC_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, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 13310188
• Report Number: 2432235-2022-00022
• Device Sequence Number: 4796579
• Product Code: KHP
• UDI-Device Identifier: 00630414287270
• UDI-Public: 00630414287270
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/20/2022

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: ATELLICA CH LACTATE_2 (LAC_2)
• Device Catalogue Number: 11532568
• Device Lot Number: 211376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/20/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown