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

Model Number ATELLICA CH LACTATE_2 (LAC_2)

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/06/2022

Event Type  malfunction  

Event Description

Discordant lactate_2 (lac_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The results were reported to the physician(s) and at least three results were questioned.These three patients were redrawn and the new samples were processed on an alternate atellica ch 930 analyzer, resulting higher.The customer is unable to provide whether additional patients will be redrawn and retested and did not quantify the number of samples impacted by this issue.This mdr is being filed in an abundance of caution as the customer did not provide details of all affected samples.There are no known reports of patient intervention or adverse health consequences due to the discordant lac_2 results.

Manufacturer Narrative

A united states customer contacted a siemens customer care center to report discordant lactate_2 (lac_2) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The customer determined that these patient results were generated from a reagent pack that was incorrectly prepared by the customer.Additionally, quality controls was out of range on the reagent pack.Siemens further investigated the issue and determined the probable cause of the discordant patient results was due to preanalytical error, in which the customer did not follow the atellica ch lactate_2 (lac_2) instructions for use for the proper preparation of the reagents.The cause of the discordant lac_2 results is due to user error.This mdr is being filed in an abundance of caution.The instrument and reagent are performing to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA CH LACTATE_2 (LAC_2)
• Type of Device: ATELLICA CH LACTATE_2 (LAC_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; registration # 8020890; crumlin co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 13607756
• MDR Text Key: 296485133
• Report Number: 2432235-2022-00056
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• 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
• Date Manufacturer Received: 02/07/2022
• 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