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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  malfunction  

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 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.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2023-00156 on aug 07, 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)
• Type of Device: 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: 17469004
• MDR Text Key: 320508760
• Report Number: 1219913-2023-00156
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 00630414287270
• UDI-Public: 00630414287270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1