MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH LACTATE_2 (LAC_2); ACID, LACTIC, ENZYMATIC METHOD

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	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states reported observation of falsely depressed lactate_2 (lac_2) results on multiple patient(s) samples on atellica ch analyzer.The initial results were reported to the physician(s), who questioned the results.The samples were repeated on the same atellica ch analyzer, and the results were higher.The higher results were considered as correct by the physician(s).The interpretation of results section of the atellica ch lactate_2 (lac_2) instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens has reviewed the information provided and concludes that this issue is user error.Customer had prepared reagents incorrectly.After proper reagent preparation as per atellica ch lactate_2 (lac_2) instructions for use (ifu), quality control (qc) results returned to normal.The system is operational.A separate mdr was filed for a different date of the same event.
Event or Problem Description
The customer reported observation of falsely depressed lactate_2 (lac_2) results on multiple patient(s) samples on atellica ch analyzer.The initial results were reported to the physician(s), who questioned the results.The samples were repeated on the same atellica ch analyzer, and the results were higher.The higher results were considered as correct by the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed lactate_2 (lac_2) results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00155 on (b)(6) 2023.Additional information - aug 07, 2023: mdr 1219913-2023-00155 was filed for the results generated on the (b)(6) 2023 and mdr 1219913-2023-00156 was filed for the results generated on (b)(6) 2023.

• Brand Name: ATELLICA CH LACTATE_2 (LAC_2)
• Common Device Name: ACID, LACTIC, ENZYMATIC METHOD
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim BT29 4QY; UK BT29 4QY
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17469009
• Report Number: 1219913-2023-00155
• Device Sequence Number: 5900241
• Product Code: KHP
• UDI-Device Identifier: 00630414287270
• UDI-Public: 00630414287270
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 11532568
• Device Lot Number: 221854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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